Trial Outcomes & Findings for A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579) (NCT NCT01716234)

Last Updated: 2018-08-27

Results Overview

Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \<2 years of age weighing \<6.5 kg.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

142 participants

Primary outcome timeframe

Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)

Results posted on

2018-08-27

Participant Flow

A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to \<2 years to receive posaconazole 18 mg/kg/day TID was never initiated.

Participant milestones

Participant milestones
Measure	POS 12 BID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Overall Study STARTED	24	22	20	28	15	32	1
Overall Study Treated	22	21	19	28	15	30	1
Overall Study COMPLETED	14	12	15	16	10	18	1
Overall Study NOT COMPLETED	10	10	5	12	5	14	0

Reasons for withdrawal

Reasons for withdrawal
Measure	POS 12 BID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Overall Study Protocol Violation	0	0	0	1	1	1
Overall Study Lack of Efficacy	0	0	0	1	0	0
Overall Study Did not meet protocol eligibility	0	0	1	0	0	4
Overall Study Adverse Event	7	10	2	8	3	6
Overall Study Withdrawal by Subject	3	0	2	2	1	3

Baseline Characteristics

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	POS 12 BID 2 to <7 Years n=24 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years n=22 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years n=20 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years n=28 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years n=15 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years n=32 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years n=1 Participants Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	Total n=142 Participants Total of all reporting groups
Age, Continuous	4.0 Years STANDARD_DEVIATION 1.3 • n=5 Participants	11.9 Years STANDARD_DEVIATION 3.5 • n=7 Participants	4.4 Years STANDARD_DEVIATION 1.5 • n=5 Participants	12.2 Years STANDARD_DEVIATION 3.2 • n=4 Participants	4.1 Years STANDARD_DEVIATION 1.3 • n=21 Participants	13.1 Years STANDARD_DEVIATION 3.0 • n=8 Participants	0.9 Years STANDARD_DEVIATION 0 • n=8 Participants	8.9 Years STANDARD_DEVIATION 4.9 • n=24 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	14 Participants n=8 Participants	0 Participants n=8 Participants	59 Participants n=24 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	19 Participants n=4 Participants	9 Participants n=21 Participants	18 Participants n=8 Participants	1 Participants n=8 Participants	83 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)

Population: The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.

Outcome measures

Outcome measures
Measure	POS 12 BID 2 to <7 Years n=22 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years n=19 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years n=12 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years n=12 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years n=5 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years n=10 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years n=1 Participants Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	122 ng/mL Standard Deviation 101	107 ng/mL Standard Deviation 92.5	112 ng/mL Standard Deviation 86.9	113 ng/mL Standard Deviation 100	68.4 ng/mL Standard Deviation 40.4	57.9 ng/mL Standard Deviation 30.2	68.5 ng/mL Standard Deviation 0

PRIMARY outcome

Timeframe: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose

Population: The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.

Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \<2500 ng/mL.

Outcome measures

Outcome measures
Measure	POS 12 BID 2 to <7 Years n=16 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years n=14 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years n=12 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years n=12 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years n=5 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years n=10 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years n=1 Participants Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	604 ng/mL Standard Deviation 779	1050 ng/mL Standard Deviation 789	485 ng/mL Standard Deviation 306	1240 ng/mL Standard Deviation 1400	620 ng/mL Standard Deviation 411	1150 ng/mL Standard Deviation 750	453 ng/mL Standard Deviation 0

SECONDARY outcome

Timeframe: Up to Day 58

Population: The population analyzed was all treated participants.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.

Outcome measures

Outcome measures
Measure	POS 12 BID 2 to <7 Years n=22 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years n=21 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years n=19 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years n=28 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years n=15 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years n=30 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years n=1 Participants Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Number of Participants With an Adverse Event	21 Participants	21 Participants	16 Participants	26 Participants	13 Participants	30 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The population analyzed was all treated participants.

Outcome measures

Outcome measures
Measure	POS 12 BID 2 to <7 Years n=22 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Years n=21 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Years n=19 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Years n=28 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Years n=15 Participants Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Years n=30 Participants Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Years n=1 Participants Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Number of Participants With an Adverse Event Leading to Study Drug Discontinuation	7 Participants	9 Participants	2 Participants	9 Participants	3 Participants	6 Participants	0 Participants

Adverse Events

POS 12 BID 2 to <7 Yrs

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

POS 12 BID 7 to <18 Yrs

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

POS 18 BID 2 to <7 Yrs

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

POS 18 BID 7 to <18 Yrs

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

POS 18 TID 2 to <7 Yrs

Serious events: 7 serious events

Other events: 13 other events

Deaths: 0 deaths

POS 18 TID 7 to <18 Yrs

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

POS 12 TID 3 Months to <2 Yrs

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	POS 12 BID 2 to <7 Yrs n=22 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Yrs n=21 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Yrs n=19 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Yrs n=28 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Yrs n=15 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Yrs n=30 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Yrs n=1 participants at risk Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Investigations Chemotherapeutic drug level increased	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Anaemia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	33.3% 5/15 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	16.7% 5/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	100.0% 1/1 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Cardiac disorders Bradycardia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Nausea	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Hypothermia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Mucosal inflammation	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Multi-organ failure	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Pyrexia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Hepatobiliary disorders Hepatic vein occlusion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Immune system disorders Anaphylactic reaction	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Catheter site cellulitis	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Pneumonia klebsiella	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Puncture site infection	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Sepsis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Streptococcal bacteraemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Alanine aminotransferase increased	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Electrocardiogram T wave inversion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Transaminases increased	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma recurrent	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Nervous system disorders Headache	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Nervous system disorders Seizure	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Renal and urinary disorders Acute kidney injury	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Renal and urinary disorders Renal failure	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Menorrhagia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Hypotension	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.

Other adverse events

Other adverse events
Measure	POS 12 BID 2 to <7 Yrs n=22 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 12 BID 7 to <18 Yrs n=21 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 2 to <7 Yrs n=19 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 BID 7 to <18 Yrs n=28 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.	POS 18 TID 2 to <7 Yrs n=15 participants at risk Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 18 TID 7 to <18 Yrs n=30 participants at risk Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.	POS 12 TID 3 Months to <2 Yrs n=1 participants at risk Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Blood and lymphatic system disorders Anaemia	18.2% 4/22 • Number of events 6 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	15.8% 3/19 • Number of events 6 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	28.6% 8/28 • Number of events 12 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 3/15 • Number of events 11 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 6/30 • Number of events 12 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	19.0% 4/21 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 4/28 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	26.7% 4/15 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	16.7% 5/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Leukopenia	22.7% 5/22 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Lymphopenia	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Neutropenia	75.0% 3/4 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Blood and lymphatic system disorders Thrombocytopenia	36.4% 8/22 • Number of events 19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	33.3% 7/21 • Number of events 15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	15.8% 3/19 • Number of events 10 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	21.4% 6/28 • Number of events 22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	16.7% 5/30 • Number of events 8 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Cardiac disorders Bradycardia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Cardiac disorders Sinus tachycardia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Cardiac disorders Tachycardia	13.6% 3/22 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Congenital, familial and genetic disorders Antithrombin III deficiency	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Ear and labyrinth disorders Ear pain	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Conjunctival hyperaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Dry eye	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Eye movement disorder	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Eye pruritus	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Eye swelling	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Eyelid oedema	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Abdominal pain	31.8% 7/22 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	28.6% 6/21 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 3/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Abdominal pain upper	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Ascites	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Constipation	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	19.0% 4/21 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Diarrhoea	22.7% 5/22 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	15.8% 3/19 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	25.0% 7/28 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 3/15 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	16.7% 5/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Dyspepsia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Gingival pain	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Lip dry	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Loose tooth	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Nausea	22.7% 5/22 • Number of events 8 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	32.1% 9/28 • Number of events 9 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 3/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	43.3% 13/30 • Number of events 21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Oral pain	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Proctitis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Retching	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Stomatitis	13.6% 3/22 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 4/28 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	33.3% 5/15 • Number of events 9 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 6/30 • Number of events 8 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Tongue coated	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Vomiting	36.4% 8/22 • Number of events 13 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	26.3% 5/19 • Number of events 6 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	39.3% 11/28 • Number of events 14 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	46.7% 7/15 • Number of events 11 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	30.0% 9/30 • Number of events 14 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Catheter site erythema	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Catheter site pruritus	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Chills	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Device occlusion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Fatigue	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 6/30 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Mucosal inflammation	40.9% 9/22 • Number of events 9 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	25.0% 7/28 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Oedema	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Pain	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Pyrexia	59.1% 13/22 • Number of events 14 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	38.1% 8/21 • Number of events 9 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	15.8% 3/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	28.6% 8/28 • Number of events 10 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 6/30 • Number of events 7 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Vessel puncture site pain	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Immune system disorders Engraftment syndrome	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Immune system disorders Graft versus host disease in skin	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Alpha haemolytic streptococcal infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Bacteraemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Gingivitis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Respiratory tract infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	100.0% 1/1 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Rhinitis	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Viral infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Vulvitis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Procedural headache	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Transfusion reaction	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Alanine aminotransferase increased	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Aspartate aminotransferase increased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Biopsy skin	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Blood bilirubin increased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Electrocardiogram QT prolonged	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Fluid balance positive	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations International normalised ratio decreased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Lymphocyte count decreased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Neutrophil count decreased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Platelet count decreased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 11 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 11 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Transaminases increased	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations White blood cell count decreased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Decreased appetite	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	20.0% 3/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	26.7% 8/30 • Number of events 9 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Fluid overload	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hyperalbuminaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypokalaemia	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 6 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	26.7% 4/15 • Number of events 6 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypomagnesaemia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	19.0% 4/21 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Metabolism and nutrition disorders Hypophosphataemia	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Musculoskeletal and connective tissue disorders Bone pain	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Nervous system disorders Dizziness	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Nervous system disorders Dysgeusia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	28.6% 8/28 • Number of events 10 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Psychiatric disorders Abnormal behavior	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Psychiatric disorders Agitation	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Psychiatric disorders Hallucination	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Psychiatric disorders Insomnia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Renal and urinary disorders Dysuria	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Renal and urinary disorders Proteinuria	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Genital pain	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Genital rash	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Pruritus genital	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	15.8% 3/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 1/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 4/30 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	7.1% 2/28 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Dermatitis	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Erythema	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Petechiae	9.1% 2/22 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	9.5% 2/21 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Pruritus	13.6% 3/22 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	23.8% 5/21 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.0% 3/30 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Rash	18.2% 4/22 • Number of events 4 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.5% 2/19 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 4/28 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	16.7% 5/30 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Red man syndrome	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Surgical and medical procedures Central venous catheter removal	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Surgical and medical procedures Central venous catheterisation	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Flushing	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Hypertension	18.2% 4/22 • Number of events 5 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Hypotension	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	14.3% 3/21 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	10.7% 3/28 • Number of events 3 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	13.3% 2/15 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 2/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Venoocclusive disease	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/19 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	6.7% 1/15 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Eye disorders Photophobia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Abdominal distension	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Enteritis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Gastrointestinal disorders Proctalgia	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Local swelling	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
General disorders Oedema peripheral	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Cellulitis	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Clostridium difficile infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Cystitis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Sinusitis	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Streptococcal infection	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Infections and infestations Viraemia	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Contusion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.3% 1/30 • Number of events 2 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Fall	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Injury, poisoning and procedural complications Skin abrasion	4.5% 1/22 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Blood glucose increased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Gamma-glutamyltransferase increased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	3.6% 1/28 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Investigations Weight increased	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Genital ulceration	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Reproductive system and breast disorders Penile oedema	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	4.8% 1/21 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.
Vascular disorders Pallor	0.00% 0/22 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/21 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	5.3% 1/19 • Number of events 1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/28 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/15 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/30 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.	0.00% 0/1 • All AEs: from Day 1 up to Day 39; SAEs: up to Day 58. The population analyzed is all treated participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy, fair balance, and compliance.
Publication restrictions are in place

Restriction type: OTHER