Trial Outcomes & Findings for Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months (NCT NCT00628108)

NCT ID: NCT00628108

Last Updated: 2015-03-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline, 14 days
• Results posted on: 2015-03-06

Participant Flow

One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group. All results are presented for the safety population for which the subjects were analyzed as treated.

Participant milestones

Measure	Placebo Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Study STARTED	23	46
Overall Study Safety Population	24	45
Overall Study COMPLETED	22	43
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Placebo Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months

Baseline characteristics by cohort

Measure	Placebo n=24 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=45 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=5 Participants	45 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.03 months STANDARD_DEVIATION 1.80 • n=5 Participants	8.87 months STANDARD_DEVIATION 1.63 • n=7 Participants	8.93 months STANDARD_DEVIATION 1.67 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	28 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	45 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)	-7.6 beats per minute Standard Deviation 17.3	-4.0 beats per minute Standard Deviation 16.9

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

The RR interval refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	28.0 milliseconds Standard Deviation 63.9	14.9 milliseconds Standard Deviation 58.4

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

The PR interval refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	0.8 milliseconds Standard Deviation 11.3	3.1 milliseconds Standard Deviation 11.3

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	1.4 milliseconds Standard Deviation 6.4	0.3 milliseconds Standard Deviation 5.7

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

The QT interval refers to the respective time in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	4.5 milliseconds Standard Deviation 21.1	-0.3 milliseconds Standard Deviation 18.7

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

The QT interval refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=20 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=38 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)	-1.3 milliseconds Standard Deviation 20.9	-3.9 milliseconds Standard Deviation 17.3

PRIMARY outcome

Timeframe: 7 days

Population: Safety Population; only non-missing values were analyzed

The QT interval refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=21 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=42 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)	360.3 milliseconds Standard Deviation 15.2	354.5 milliseconds Standard Deviation 21.1

PRIMARY outcome

Timeframe: 14 days

Population: Safety Population; only non-missing values were analyzed

The QT interval refers to the respective time interval in the Electrocardiogram (ECG)

Outcome measures

Measure	Placebo n=23 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=39 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)	355.3 milliseconds Standard Deviation 17.7	351.9 milliseconds Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=19 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=35 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin	0.000 micromole per liter [µmol/L] Interval -1.71 to 1.71	0.000 micromole per liter [µmol/L] Interval -3.42 to 3.42

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=19 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=34 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)	-2.0 unit per liter [U/L] Interval -27.0 to 15.0	-1.0 unit per liter [U/L] Interval -24.0 to 41.0

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=19 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=34 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)	2.0 unit per liter [U/L] Interval -15.0 to 21.0	-1.0 unit per liter [U/L] Interval -36.0 to 23.0

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=19 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=36 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen	0.0000 millimole per liter [mmol/L] Interval -0.714 to 2.856	0.0000 millimole per liter [mmol/L] Interval -3.927 to 4.641

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Safety Population; only non-missing values were analyzed

Outcome measures

Measure	Placebo n=19 Participants Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=36 Participants Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine	-0.8840 micromole per liter [μmol/L] Interval -9.724 to 20.332	-0.8840 micromole per liter [μmol/L] Interval -18.564 to 10.608

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Levocetirizine

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=24 participants at risk Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=45 participants at risk Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Infections and infestations Otitis media acute	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Acute sinusitis	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Upper respiratory tract infection	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.

Other adverse events

Measure	Placebo n=24 participants at risk Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).	Levocetirizine n=45 participants at risk Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Cardiac disorders Sinus arrhythmia	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Cardiac disorders Sinus bradycardia	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Ear and labyrinth disorders Ear pruritus	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Eye disorders Eye discharge	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Gastrointestinal disorders Diarrhoea	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	13.3% 6/45 • Number of events 6 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Gastrointestinal disorders Teething	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	6.7% 3/45 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	6.7% 3/45 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Gastrointestinal disorders Vomiting	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	4.4% 2/45 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
General disorders Pyrexia	16.7% 4/24 • Number of events 4 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	15.6% 7/45 • Number of events 7 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
General disorders Irritability	12.5% 3/24 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
General disorders Thirst	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
General disorders Injection site pain	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Otitis media	8.3% 2/24 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	4.4% 2/45 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Upper respiratory tract infection	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Sinusitis	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Viral infection	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Gastroenteritis	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Oral candidiasis	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Bronchitis acute	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Infections and infestations Skin infection	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Metabolism and nutrition disorders Increased appetite	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Nervous system disorders Somnolence	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	4.4% 2/45 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Psychiatric disorders Insomnia	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Productive cough	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.2% 1/24 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	4.4% 2/45 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Wheezing	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Dermatitis diaper	12.5% 3/24 • Number of events 3 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Eczema	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	2.2% 1/45 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Heat rash	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Rash papular	8.3% 2/24 • Number of events 2 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
Skin and subcutaneous tissue disorders Pruritus	4.2% 1/24 • Number of events 1 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.	0.00% 0/45 • Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2). Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.

Additional Information

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