Trial Outcomes & Findings for Stannsoporfin With Light Therapy for Newborn Babies With Jaundice (NCT NCT01887327)

NCT ID: NCT01887327

Last Updated: 2020-02-06

Results Overview

Total serum bilirubin (TSB) was measured at baseline (the measure that qualified the baby for inclusion) and at 48 hours after treatment. If a baby was discharged before 48 hours, the last measurement before discharge was used \[last observation carried forward (LOCF)\].

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 91 participants
• Primary outcome timeframe: Baseline, 48 hours post-treatment
• Results posted on: 2020-02-06

Participant Flow

Participant milestones

Measure	3.0 mg/kg Stannsoporfin Participants receive 3.0 mg/kg Stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin Participants receive 4.5 mg/kg stannsoporfin and phototherapy	Placebo Participants receive placebo and phototherapy
Overall Study STARTED	30	31	30
Overall Study COMPLETED	29	27	27
Overall Study NOT COMPLETED	1	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

Baseline characteristics by cohort

Measure	3.0 mg/kg Stannsoporfin n=30 Participants Participants receive 3.0 mg/kg Stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin n=31 Participants Participants receive 4.5 mg/kg stannsoporfin and phototherapy	Placebo n=30 Participants Participants receive placebo and phototherapy	Total n=91 Participants Total of all reporting groups
Age, Continuous	21.66 Hour STANDARD_DEVIATION 11.417 • n=5 Participants	24.05 Hour STANDARD_DEVIATION 11.020 • n=7 Participants	25.92 Hour STANDARD_DEVIATION 12.361 • n=5 Participants	23.88 Hour STANDARD_DEVIATION 11.608 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	31 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	60 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age at Qualifying TSB Less than or equal to 12 h	13 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Age at Qualifying TSB Greater than 12 h to Less than or equal to 24 h	11 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants
Age at Qualifying TSB Greater than 24 h to Less than or equal to 32 h	3 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Age at Qualifying TSB Greater than 32 h to Less than or equal to 40 h	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Age at Qualifying TSB Greater than 40 h	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 48 hours post-treatment

Population: Intention to treat (ITT) analysis set

Total serum bilirubin (TSB) was measured at baseline (the measure that qualified the baby for inclusion) and at 48 hours after treatment. If a baby was discharged before 48 hours, the last measurement before discharge was used [last observation carried forward (LOCF)].

Outcome measures

Measure	3.0 mg/kg Stannsoporfin n=30 Participants Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin n=31 Participants Participants receive 4.5 mg/kg Stannsoporfin and phototherapy	Placebo n=30 Participants Participants receive placebo and phototherapy
Total Serum Bilirubin (mg/dL) Baseline	9.82 mg/dL Standard Deviation 2.641	9.97 mg/dL Standard Deviation 2.967	9.92 mg/dL Standard Deviation 2.211
Total Serum Bilirubin (mg/dL) 48 hours post-treatment	8.48 mg/dL Standard Deviation 1.973	8.86 mg/dL Standard Deviation 2.142	11.67 mg/dL Standard Deviation 2.337

SECONDARY outcome

Timeframe: within 54 hours

Population: ITT Analysis Set minus 2 participants who received placebo and did not reach the defined threshold for their age within 54 hours

The hour that 50% of babies in the group (median) first crosses at or below the defined 54-hour threshold for the baby's age

Outcome measures

Measure	3.0 mg/kg Stannsoporfin n=30 Participants Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin n=31 Participants Participants receive 4.5 mg/kg Stannsoporfin and phototherapy	Placebo n=28 Participants Participants receive placebo and phototherapy
Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)	11.8 hours Interval -3.7 to 53.6	10.6 hours Interval -5.5 to 28.5	20.9 hours Interval -4.4 to 54.0

SECONDARY outcome

Timeframe: within 30 days after discharge

Population: Intention to treat

PT failure was defined by any of the following:

• re-start of PT within 6 hours after stopping
• re-hospitalization for hyperbilirubinaemia
• use of intravenous immunoglobulin (IVIg)
• need for an exchange transfusion

Outcome measures

Measure	3.0 mg/kg Stannsoporfin n=30 Participants Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin n=31 Participants Participants receive 4.5 mg/kg Stannsoporfin and phototherapy	Placebo n=30 Participants Participants receive placebo and phototherapy
Number of Participants With Phototherapy (PT) Failure PT failure Occurred	3 Participants	1 Participants	8 Participants
Number of Participants With Phototherapy (PT) Failure Did not occur	27 Participants	30 Participants	22 Participants

SECONDARY outcome

Timeframe: within 54 hours

Population: Intention to treat

Rebound hyperbilirubinaemia was defined as an increase in TSB above the age-specific threshold for initiating phototherapy, following the discontinuation of the initial phototherapy.

Outcome measures

Measure	3.0 mg/kg Stannsoporfin n=30 Participants Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5 mg/kg Stannsoporfin n=31 Participants Participants receive 4.5 mg/kg Stannsoporfin and phototherapy	Placebo n=30 Participants Participants receive placebo and phototherapy
Number of Participants With Rebound Hyperbilirubinemia Occurred	0 Participants	1 Participants	3 Participants
Number of Participants With Rebound Hyperbilirubinemia Did not occur	30 Participants	30 Participants	27 Participants

Adverse Events

3.0 mg/kg Stannsoporfin

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

4.5mg/kg Stannsoporfin

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	3.0 mg/kg Stannsoporfin n=30 participants at risk Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5mg/kg Stannsoporfin n=31 participants at risk Participants receive 4.5mg/kg stannsoporfin and phototherapy	Placebo n=30 participants at risk Participants receive placebo and phototherapy
Blood and lymphatic system disorders Leukocytosis	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Cardiac disorders Supraventricular tachycardia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Hepatobiliary disorders Hyperbilirubinaemia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Immune system disorders ABO incompatibility	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Bacterial sepsis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Meningitis viral	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Sepsis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Hematocrit decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Haemoglobin decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Medical observation	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Reticulocyte count increased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Tachypnoea	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.

Other adverse events

Measure	3.0 mg/kg Stannsoporfin n=30 participants at risk Participants receive 3.0 mg/kg stannsoporfin and phototherapy	4.5mg/kg Stannsoporfin n=31 participants at risk Participants receive 4.5mg/kg stannsoporfin and phototherapy	Placebo n=30 participants at risk Participants receive placebo and phototherapy
Infections and infestations Viral Infection	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Injury, poisoning and procedural complications Excoriation	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Injury, poisoning and procedural complications Sunburn	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Aspartate Aminotransferase Increased	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Bilirubin Conjugated Increased	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Blood Bicarbonate Decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Blood and lymphatic system disorders Anaemia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Blood and lymphatic system disorders Haemolytic anaemia	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Blood and lymphatic system disorders Thrombocytopenia	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Congenital naevus	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.5% 2/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Eye disorders Conjucunctival Hemorrhage	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Gastrointestinal disorders Umbilical hernia	13.3% 4/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
General disorders Fat Tissue Increased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Hepatobiliary disorders Hyperbilirubinaemia	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Bacterial Sepsis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Injury, poisoning and procedural complications Scratch	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Cardiac murmur	16.7% 5/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	12.9% 4/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	13.3% 4/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Gamma-glutamyl transferase increased	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Haematocrit decreased	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.5% 2/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Haemoglobin decreased	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Medical observation	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Reticulocyte count increased	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	9.7% 3/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Metabolism and nutrition disorders Abnormal Loss Of Weight	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Acne infantile	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Dermatitis diaper	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Dry skin	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	9.7% 3/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Erythema	16.7% 5/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	16.1% 5/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Erythema toxicum neonatorum	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.5% 2/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Milia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Seborrhoea	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	6.7% 2/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	10.0% 3/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Blood and lymphatic system disorders Leukocytosis	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Blood and lymphatic system disorders Platelet Toxicity	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Cardiac disorders Supraventricular Tachycardia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Cardiac disorders Ventricular Hypertrophy	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Ankyloglossia Congenital	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Atrial Septal Defect	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Dacryostenosis Congenital	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Congenital, familial and genetic disorders Patent Ductus Arteriosus	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Ear and labyrinth disorders Middle Ear Effusion	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Eye disorders Eye Discharge	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Eye disorders Ocular Icterus	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Eye disorders Retinal Haemorrhage	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Eye disorders Strabismus	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Gastrointestinal disorders Constipation	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Gastrointestinal disorders Infantile Colic	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Gastrointestinal disorders Infantile Vomiting	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Gastrointestinal disorders Vomiting	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
General disorders Injection Site Erythema	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Immune system disorders Abo Incompatibility	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Candida Nappy Rash	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Fungal Infection	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Meningitis Viral	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Oral Candidiasis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Otitis Media	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Sepsis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Infections and infestations Skin Candida	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Blood Bilirubin Increased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Carbon Dioxide Decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Haematocrit Abnormal	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Neutrophil Count Decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Platelet Count Decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Red Blood Cell Count Decreased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations Respiratory Syncytial Virus Test Positive	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Investigations White Blood Cell Count Increased	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Metabolism and nutrition disorders Feeding Intolerance	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Metabolism and nutrition disorders Hyperkalaemia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Metabolism and nutrition disorders Hypocalcaemia	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Nervous system disorders Hypotonia	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Nervous system disorders Lethargy	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Nervous system disorders Tremor	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Pregnancy, puerperium and perinatal conditions Umbilical Granuloma	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Pregnancy, puerperium and perinatal conditions Jaundice Neonatal	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Reproductive system and breast disorders Penile Haemorrhage	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Neonatal Hypoxia	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Tachypnoea	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Cafe Au Lait Spots	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Exfoliative Rash	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Generalised Erythema	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Melanosis	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Papule	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash Erythematous	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.2% 1/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash Neonatal	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash Papular	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Skin Disorder	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Skin Sensitisation	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.
Skin and subcutaneous tissue disorders Transient Neonatal Pustular Melanosis	0.00% 0/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	0.00% 0/31 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.	3.3% 1/30 • within 30 Days Only treatment-emergent adverse events are reported. Treatment-emergent adverse events are those that started or got worse after treatment. Participants with multiple occurrences of a preferred term were counted only once for that preferred term.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place