Trial Outcomes & Findings for Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics (NCT NCT01563081)

Last Updated: 2017-02-28

Results Overview

A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of \>=5%, please see the SAE/non-serious AE module of this record.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

up to Week 2/Early Withdrawal (EW)

Results posted on

2017-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Levocetirizine: >=6 Months and <12 Months Old Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levocetirizine: >=6 Months and <12 Months Old n=30 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old n=30 Participants Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Total n=60 Participants Total of all reporting groups
Age, Continuous	8.1 Months STANDARD_DEVIATION 1.94 • n=5 Participants	15.8 Months STANDARD_DEVIATION 2.56 • n=7 Participants	12.0 Months STANDARD_DEVIATION 4.46 • n=5 Participants
Gender Female	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Gender Male	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Mixed Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Number of participants with the indicated primary disease at Baseline Allergic rhinitis	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Number of participants with the indicated primary disease at Baseline Pruritus associated with the skin diseases	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: up to Week 2/Early Withdrawal (EW)

Population: Safety Population : all participants who participated in this study and who received at least one dose of medication

Outcome measures

Outcome measures
Measure	Levocetirizine: >=6 Months and <12 Months Old n=30 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old n=30 Participants Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population n=60 Participants Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) Any Adverse Event	15 participants	17 participants	32 participants
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) Any Serious Adverse Event	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Population: Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product

The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis \[AR\]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal \[EW\] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The "n"s in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline.

Outcome measures

Outcome measures
Measure	Levocetirizine: >=6 Months and <12 Months Old n=60 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, significantly improved, n=20	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, significantly improved, n=20	8 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, moderately improved, n=20	5 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, moderately improved, n=20	5 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, mildly improved, n=20	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, mildly improved, n=20	5 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, no change, n=20	7 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, no change, n=20	1 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, mildly worse, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, mildly worse, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, moderately worse, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, moderately worse, n=20	1 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 1, significantly worse, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression AR, Week 2/EW, significantly worse, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, significantly improved, n=40	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, significantly improved, n=40	6 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, moderately improved, n=40	11 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, moderately improved, n=40	16 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, mildly improved, n=40	13 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, mildly improved, n=40	14 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, no change, n=40	12 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, no change, n=40	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, mildly worse, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, mildly worse, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, moderately worse, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, moderately worse, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 1, significantly worse, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression PAWSD, Week 2/EW, significantly worse, n=40	0 participants	—	—

SECONDARY outcome

Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Population: FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The "n"s in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline.

The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis \[AR\]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal \[EW\] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.

Outcome measures

Outcome measures
Measure	Levocetirizine: >=6 Months and <12 Months Old n=60 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 1, worsened, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 2/EW, worsened, n=20	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 1, markedly improved, n=40	6 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 2/EW, markedly improved, n=40	10 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 1, moderately improved, n=40	15 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 2/EW, moderately improved, n=40	19 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 1, slightly improved, n=40	12 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 2/EW, slightly improved, n=40	8 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 1, no change, n=40	7 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 2/EW, no change, n=40	3 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 1, worsened, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator PAWSD, Week 2/EW, worsened, n=40	0 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 1, markedly improved, n=20	7 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 2/EW, markedly improved, n=20	12 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week moderately improved, n=20	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 2/EW, moderately improved, n=20	3 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 1, slightly improved, n=20	3 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 2/EW, slightly improved, n=20	4 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 1, no change, n=20	6 participants	—	—
Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator AR, Week 2/EW, no change, n=20	1 participants	—	—

SECONDARY outcome

Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Population: FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.

The investigator comprehensively assessed the pariticipant's severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal \[EW\] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.

Outcome measures

Outcome measures
Measure	Levocetirizine: >=6 Months and <12 Months Old n=40 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal FDOT, none	0 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal FDOT, slight	7 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal FDOT, mild	17 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal FDOT, moderate	11 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal FDOT, severe	5 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 1, none	6 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 1, slight	14 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 1, mild	11 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 1, moderate	7 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 1, severe	2 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 2/EW, none	13 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 2/EW, slight	8 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 2/EW, mild	11 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 2/EW, moderate	8 participants	—	—
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal Week 2/EW, severe	0 participants	—	—

SECONDARY outcome

Timeframe: Weeks 1 and 2/Early Withdrawal

Population: Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations

Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the \>=6 months and \<12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the \>=12 months and \<24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.

Outcome measures

Outcome measures
Measure	Levocetirizine: >=6 Months and <12 Months Old n=30 Participants Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old n=30 Participants Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Cmax and Cmin of Levocetirizine in Plasma Cmax	206.780 nanograms per milliliter Interval 41.89 to 327.03	213.440 nanograms per milliliter Interval 17.75 to 323.42	—
Cmax and Cmin of Levocetirizine in Plasma Cmin	17.710 nanograms per milliliter Interval 3.49 to 104.46	48.330 nanograms per milliliter Interval 2.91 to 126.18	—

Adverse Events

Levocetirizine: >=6 Months and <12 Months Old

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Levocetirizine: >=12 Months and <24 Months Old

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Levocetirizine: Total Population

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levocetirizine: >=6 Months and <12 Months Old n=30 participants at risk Participants who were \>=6 months and \<12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters \[mL\] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.	Levocetirizine: >=12 Months and <24 Months Old n=30 participants at risk Participants who were \>=12 months and \<24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.	Levocetirizine: Total Population n=60 participants at risk Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were \>=6 months and \<12 months old; twice daily for participants who were \>=12 months and \<24 months old) for a duration of 2 weeks.
Infections and infestations Nasopharyngitis	0.00% 0/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	23.3% 7/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	11.7% 7/60 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Infections and infestations Gastroenteritis	3.3% 1/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	6.7% 2/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	5.0% 3/60 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	6.7% 2/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	6.7% 2/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	6.7% 4/60 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	10.0% 3/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	5.0% 3/60 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	6.7% 2/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	3.3% 1/30 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	5.0% 3/60 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal. SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.

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