Trial Outcomes & Findings for Panitumumab in Children With Solid Tumors (NCT NCT00658658)

Last Updated: 2016-05-18

Results Overview

Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.

Results posted on

2016-05-18

Participant Flow

This study was conducted at 7 centers in the United States. Participants were enrolled from 14 March 2008 to 4 March 2015.

Three dose regimens were to be tested in pediatric patients stratified by age group (1 to 11 versus 12 to 17 years). Participants were enrolled sequentially into each dose group, beginning with the 2.5 mg/kg, 12 to 17 year old cohort, based upon demonstration of sufficient safety.

Participant milestones

Participant milestones
Measure	Age 12-17: 2.5 mg/kg QW Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Overall Study STARTED	6	7	4	6	8
Overall Study COMPLETED	1	5	4	4	3
Overall Study NOT COMPLETED	5	2	0	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Age 12-17: 2.5 mg/kg QW Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Death	4	0	1	1
Overall Study Disease Progression	0	1	1	3
Overall Study Protocol-specified Criteria	1	0	0	0
Overall Study Other	0	0	0	1

Baseline Characteristics

Panitumumab in Children With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 12-17: 2.5 mg/kg QW n=6 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=6 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=8 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Total n=31 Participants Total of all reporting groups
Age, Continuous	13.2 years STANDARD_DEVIATION 0.8 • n=5 Participants	15.6 years STANDARD_DEVIATION 1.5 • n=7 Participants	15.8 years STANDARD_DEVIATION 1.9 • n=5 Participants	7.8 years STANDARD_DEVIATION 3.1 • n=4 Participants	8.4 years STANDARD_DEVIATION 2.8 • n=21 Participants	11.8 years STANDARD_DEVIATION 4.1 • n=10 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=10 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	2 participants n=10 Participants
Race/Ethnicity, Customized Black (or African American)	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	3 participants n=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	2 participants n=10 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants
Race/Ethnicity, Customized White or Caucasian	5 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	7 participants n=21 Participants	23 participants n=10 Participants

PRIMARY outcome

Timeframe: 28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.

Population: DLT Analysis Set (all participants who received at least 1 dose of panitumumab and were evaluated for DLTs and completed at least 28 days (for the 2.5 and 6 mg/kg cohorts) or 21 days (for 9 mg/kg cohort) of therapy unless due to a DLT)

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=5 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=4 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=5 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Number of Participants With Dose-limiting Toxicities (DLTs)	1 participants	0 participants	0 participants	1 participants	3 participants

PRIMARY outcome

Timeframe: From first dose date to end of study date. The median duration of study was 47 days.

Population: Safety Analysis Set (all participants who received at least 1 dose of panitumumab)

A serious adverse event is defined as an AE that: • is fatal; • is life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • other significant medical hazard. The investigator assessed whether adverse events were related to panitumumab. The severity of adverse events was based on CTCAE version 3 (with the exception of skin- or nail-related toxicities which were graded using the CTCAE version 3.0 with modifications), according to the following: Grade 1 = Mild (aware of sign or symptom, but easily tolerated); Grade 2 = Moderate (discomfort enough to cause interference with usual activity); Grade 3 = Severe (incapacitating with inability to work or do usual activity); Grade 4 = Life-threatening or disabling; Grade 5 = Fatal.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=6 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=6 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=8 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Number of Participants With Adverse Events (AEs) Any adverse event	6 participants	7 participants	3 participants	6 participants	8 participants
Number of Participants With Adverse Events (AEs) Serious adverse events	5 participants	3 participants	2 participants	3 participants	5 participants
Number of Participants With Adverse Events (AEs) Treatment-related serious adverse event	1 participants	0 participants	0 participants	1 participants	2 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse event	5 participants	5 participants	3 participants	5 participants	6 participants
Number of Participants With Adverse Events (AEs) Withdrawals due to adverse event	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events (AEs) Grade 1	5 participants	7 participants	3 participants	6 participants	6 participants
Number of Participants With Adverse Events (AEs) Grade 2	5 participants	6 participants	3 participants	4 participants	7 participants
Number of Participants With Adverse Events (AEs) Grade 3	4 participants	5 participants	2 participants	4 participants	6 participants
Number of Participants With Adverse Events (AEs) Grade 4	4 participants	0 participants	0 participants	1 participants	2 participants
Number of Participants With Adverse Events (AEs) Fatal	4 participants	0 participants	0 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).

Population: Pharmacokinetic (PK) Analysis Set (all participants who received the correct dose of panitumumab and from whom the PK parameters could be assessed); "n" indicates the number of participants with available data for each time point.

Panitumumab serum concentration was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 400 pg/mL. Concentrations below the LLOQ were set to zero.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=6 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=3 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=4 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=7 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Maximum Observed Concentration (Cmax) of Panitumumab First Dose (n=6, 7, 3, 4, 7)	52.8 μg/mL Standard Deviation 11.4	161 μg/mL Standard Deviation 41.2	205 μg/mL Standard Deviation 45.9	42.9 μg/mL Standard Deviation 8.51	120 μg/mL Standard Deviation 29.4
Maximum Observed Concentration (Cmax) of Panitumumab Third Dose (n=3, 5, 1, 3, 2)	76.6 μg/mL Standard Deviation 21.1	187 μg/mL Standard Deviation 45.2	327 μg/mL Standard Deviation NA Cannot be calculated when n = 1	60.8 μg/mL Standard Deviation 15.7	126 μg/mL Standard Deviation NA Not calculated as not considered reliable when n = 2

PRIMARY outcome

Population: PK analysis set; "n" indicates the number of participants with available data for each time point.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=2 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=4 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=5 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Minimum Observed Concentration (Cmin) of Panitumumab First Dose (n=4, 7, 2, 4, 5)	6.62 μg/mL Standard Deviation 6.83	24.7 μg/mL Standard Deviation 18.6	35.3 μg/mL Standard Deviation NA Not calculated as not considered reliable when n = 2	4.87 μg/mL Standard Deviation 3.64	19.7 μg/mL Standard Deviation 15.5
Minimum Observed Concentration (Cmin) of Panitumumab Third Dose (n=3, 5, 0, 3, 2)	24.2 μg/mL Standard Deviation 22.9	48.1 μg/mL Standard Deviation 25.1	NA μg/mL Standard Deviation NA No participants with available data	17.3 μg/mL Standard Deviation 8.83	26.1 μg/mL Standard Deviation NA Not calculated as not considered reliable when n = 2

PRIMARY outcome

Population: PK analysis set; "n" indicates the number of participants with available data for each time point.

The area under the serum concentration-time curve from time zero to the end of the dosing interval (AUCtau), estimated using the linear trapezoidal method.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=2 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=4 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=5 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab First Dose (n=4, 7, 2, 4, 5)	167 day*μg/mL Standard Deviation 86.1	1040 day*μg/mL Standard Deviation 357	1580 day*μg/mL Standard Deviation NA Not calculated as not considered reliable when n = 2	127 day*μg/mL Standard Deviation 37.9	708 day*μg/mL Standard Deviation 247
Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab Third Dose (n=3, 5, 0, 3, 2)	306 day*μg/mL Standard Deviation 178	1330 day*μg/mL Standard Deviation 357	NA day*μg/mL Standard Deviation NA No participants with available data	255 day*μg/mL Standard Deviation 70.7	754 day*μg/mL Standard Deviation NA Not calculated as not considered reliable when n = 2

PRIMARY outcome

Population: PK analysis set; "n" indicates the number of participants with available data for each time point.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=2 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=5 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=1 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=3 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=3 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab First Dose (n=2, 5, 1, 3, 3)	1.33 days Standard Deviation NA Not calculated as not considered reliable when n = 2	4.49 days Standard Deviation 1.09	4.27 days Standard Deviation NA Cannot be calculated when n = 1	2.11 days Standard Deviation 0.913	4.23 days Standard Deviation 1.64
Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab Third Dose (n=2, 2, 0, 1, 1)	2.94 days Standard Deviation NA Not calculated as not considered reliable when n = 2	4.98 days Standard Deviation NA Not calculated as not considered reliable when n = 2	NA days Standard Deviation NA No participants with available data	3.07 days Standard Deviation NA Cannot be calculated when n = 1	4.91 days Standard Deviation NA Cannot be calculated when n = 1

PRIMARY outcome

Population: PK analysis set; "n" indicates the number of participants with available data for each time point.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=3 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=5 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=1 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=4 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=3 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Serum Clearance (CL) of Panitumumab Third Dose (n=3, 5, 0, 3, 2)	9.92 mL/day/kg Standard Deviation 4.40	4.69 mL/day/kg Standard Deviation 1.00	NA mL/day/kg Standard Deviation NA No participants with available data	10.1 mL/day/kg Standard Deviation 2.44	8.05 mL/day/kg Standard Deviation NA Not calculated as not considered reliable when n = 2
Serum Clearance (CL) of Panitumumab First Dose (n=3, 5, 1, 4, 3)	19.8 mL/day/kg Standard Deviation 8.57	6.38 mL/day/kg Standard Deviation 0.466	7.15 mL/day/kg Standard Deviation NA Cannot be calculated when n = 1	18.7 mL/day/kg Standard Deviation 6.35	8.06 mL/day/kg Standard Deviation 1.40

SECONDARY outcome

Timeframe: Before panitumumab administration on Day 1, Day 43, Day 169 and 30 days after last dose for all cohorts.

Population: Safety Analysis Set participants with at least one post-baseline immunoassay result

Three validated assays were used to detect the presence of anti-panitumumab antibodies. Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. All samples confirmed to be positive by drug specificity in either screening immunoassay were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay. The number of participants who developed antibodies to panitumumab is the number of participants with a non-positive (including missing) antibody result at baseline and a positive antibody result at any post-baseline time point.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=5 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=3 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=4 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Number of Participants Who Developed Antibodies to Panitumumab Neutralizing antibodies	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Who Developed Antibodies to Panitumumab Binding antibodies	1 participants	0 participants	0 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.

Population: Safety Analysis Set participants with presence of baseline measurable disease

Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria. A participant was considered a responder if their best response was either a complete or partial response. Participants without a post-baseline assessment were considered non-responders. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response (CR): Disappearance of all target and non-target lesions, normalization of tumor markers and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) or/and maintenance of tumor marker level above normal limits, and no new lesions.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=3 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=2 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=3 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Percentage of Participants With an Objective Response	0.00 percentage of participants Interval 0.0 to 60.24	0.00 percentage of participants Interval 0.0 to 70.76	0.00 percentage of participants Interval 0.0 to 60.24	0.00 percentage of participants Interval 0.0 to 84.19	0.00 percentage of participants Interval 0.0 to 70.76

SECONDARY outcome

Population: Safety Analysis Set participants with presence of baseline measurable disease

Disease assessments were based on investigator review of scans using modified RECIST version 1.0 criteria. A participant was considered to have disease control if their best response is either a complete or partial response, or stable disease. Participants without a post-baseline assessment were considered to not have disease control. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. A best overall response of SD requires a visit response of SD or better, no earlier than 49 days after the date of enrollment. Stable disease (SD): Neither sufficient shrinkage of target lesions to qualify for a PR nor sufficient increase to qualify for PD and no progression of existing non-target lesions and no new lesions.

Outcome measures

Outcome measures
Measure	Age 12-17: 2.5 mg/kg QW n=4 Participants Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=3 Participants Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 Participants Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=2 Participants Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=3 Participants Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Percentage of Participants With Disease Control	0.00 percentage of participants Interval 0.0 to 60.24	33.33 percentage of participants Interval 0.84 to 90.57	0.00 percentage of participants Interval 0.0 to 60.24	50.00 percentage of participants Interval 1.26 to 98.74	66.67 percentage of participants Interval 9.43 to 99.16

Adverse Events

Age 12-17: 2.5 mg/kg QW

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Age 12-17: 6 mg/kg Q2W

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Age 12-17: 9 mg/kg Q3W

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Age 1-11: 2.5 mg/kg QW

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Age 1-11: 6 mg/kg Q2W

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age 12-17: 2.5 mg/kg QW n=6 participants at risk Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 participants at risk Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 participants at risk Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=6 participants at risk Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=8 participants at risk Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Cardiac disorders Tachycardia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Ascites	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Pancreatitis	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Pyrexia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Alanine aminotransferase increased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood urea increased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Haemoglobin decreased	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperuricaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rhabdomyosarcoma	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Cerebral haemorrhage	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Seizure	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Acute kidney injury	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Hydronephrosis	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Oliguria	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Apnoea	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Vascular disorders Hypotension	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.

Other adverse events

Other adverse events
Measure	Age 12-17: 2.5 mg/kg QW n=6 participants at risk Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 6 mg/kg Q2W n=7 participants at risk Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 12-17: 9 mg/kg Q3W n=4 participants at risk Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 2.5 mg/kg QW n=6 participants at risk Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.	Age 1-11: 6 mg/kg Q2W n=8 participants at risk Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Cardiac disorders Bradycardia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Cardiac disorders Palpitations	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Cardiac disorders Tachycardia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Endocrine disorders Cushingoid	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Diplopia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Dry eye	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Erythema of eyelid	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Exophthalmos	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Lacrimation increased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Ocular hyperaemia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Eye disorders Vision blurred	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Change of bowel habit	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	50.0% 3/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	42.9% 3/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	37.5% 3/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Gingival bleeding	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Gingival erythema	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	37.5% 3/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Oral pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	66.7% 4/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Chest pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Chills	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Fatigue	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	57.1% 4/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Hypothermia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Localised oedema	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Mucosal inflammation	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Non-cardiac chest pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Oedema	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Oedema peripheral	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
General disorders Pyrexia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Immune system disorders Cytokine release syndrome	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Immune system disorders Hypersensitivity	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Cystitis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Herpes virus infection	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Infection	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Influenza	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Nasopharyngitis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Oral candidiasis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Oral fungal infection	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Oral herpes	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Peritonitis	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Purulent discharge	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Rash pustular	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Sinusitis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Skin infection	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Streptococcal infection	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Infections and infestations Urinary tract infection	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood albumin decreased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood bicarbonate decreased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood creatinine	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood glucose increased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood lactate dehydrogenase decreased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Blood potassium decreased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Haemoglobin	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Haemoglobin decreased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Heart rate increased	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Lymphocyte count decreased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Neutrophil count decreased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Platelet count decreased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations Temperature difference of extremities	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Investigations White blood cell count decreased	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Acidosis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Alkalosis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypokalaemia	50.0% 3/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Hypophosphataemia	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Bone atrophy	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Amnesia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Cerebellar syndrome	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Cognitive disorder	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Cranial nerve disorder	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Dizziness	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Headache	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Hemiplegia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Hyperaesthesia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Motor dysfunction	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Nystagmus	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Peripheral motor neuropathy	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Phantom pain	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Abnormal behaviour	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Agitation	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Anxiety	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Confusional state	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Depressed mood	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Depression	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Disorientation	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Psychiatric disorders Irritability	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Dysuria	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Renal and urinary disorders Urogenital haemorrhage	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Reproductive system and breast disorders Acquired phimosis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	42.9% 3/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	71.4% 5/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	57.1% 4/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	37.5% 3/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Erythema	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	50.0% 2/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Petechiae	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	28.6% 2/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	12.5% 1/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	33.3% 2/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 2/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Vascular disorders Hypertension	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Vascular disorders Hypotension	16.7% 1/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	25.0% 1/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Vascular disorders Pallor	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	14.3% 1/7 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/4 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/6 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.	0.00% 0/8 • From first dose date to end of study date. The median duration of study is 47 days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

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

Restriction type: OTHER