Trial Outcomes & Findings for Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin (NCT NCT00619801)
NCT ID: NCT00619801
Last Updated: 2015-03-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Baseline, 14 days
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
114
|
|
Overall Study
Safety Population
|
59
|
114
|
|
Overall Study
COMPLETED
|
58
|
111
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Loss of efficacy
|
0
|
1
|
Baseline Characteristics
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=114 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
173 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
|
3.75 years
STANDARD_DEVIATION 1.45 • n=5 Participants
|
3.78 years
STANDARD_DEVIATION 1.38 • n=7 Participants
|
3.77 years
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
114 participants
n=7 Participants
|
173 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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)
|
-1.5 beats per minute
Standard Deviation 14.1
|
1.3 beats per minute
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: 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=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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
|
9.2 milliseconds
Standard Deviation 85.9
|
-6.9 milliseconds
Standard Deviation 83.4
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: 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=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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
|
0.5 milliseconds
Standard Deviation 9.6
|
-0.8 milliseconds
Standard Deviation 11.0
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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
|
0.3 milliseconds
Standard Deviation 6.6
|
0.9 milliseconds
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: 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=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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
|
-2.8 milliseconds
Standard Deviation 17.2
|
-1.5 milliseconds
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: 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=56 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=110 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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)
|
-5.5 milliseconds
Standard Deviation 14.3
|
-0.3 milliseconds
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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=57 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=112 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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)
|
372.6 milliseconds
Standard Deviation 16.5
|
368.9 milliseconds
Standard Deviation 19.4
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 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=57 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=111 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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)
|
369.8 milliseconds
Standard Deviation 17.1
|
370.5 milliseconds
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=104 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 -10.26 to 3.42
|
0.000 micromole per liter [µmol/L]
Interval -8.55 to 5.13
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=105 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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)
|
-1.5 unit per liter [U/L]
Interval -12.0 to 167.0
|
1.0 unit per liter [U/L]
Interval -21.0 to 138.0
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=53 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=105 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 Aminotransferase (AST)
|
-1.0 unit per liter [U/L]
Interval -15.0 to 52.0
|
1.0 unit per liter [U/L]
Interval -16.0 to 58.0
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=105 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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
|
-0.1785 millimole per liter [mmol/L]
Interval -2.142 to 2.142
|
0.0000 millimole per liter [mmol/L]
Interval -3.57 to 3.213
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Safety Population; only non-missing values were analyzed
Outcome measures
| Measure |
Placebo
n=54 Participants
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=105 Participants
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice 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 -17.68 to 13.26
|
1.7680 micromole per liter [µmol/L]
Interval -15.912 to 16.796
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Levocetirizine
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=59 participants at risk
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=114 participants at risk
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
Levocetirizine
n=114 participants at risk
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Eye disorders
Eye swelling
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • 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 treatment at least once.
|
3.5%
4/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/59 • 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 treatment at least once.
|
3.5%
4/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Teething
|
1.7%
1/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
General disorders
Pyrexia
|
1.7%
1/59 • 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 treatment at least once.
|
4.4%
5/114 • Number of events 5 • 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 treatment at least once.
|
|
General disorders
Fatigue
|
1.7%
1/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
General disorders
Pain
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
General disorders
Hunger
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
General disorders
Thirst
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
2/59 • 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 treatment at least once.
|
2.6%
3/114 • 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 treatment at least once.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Otitis media
|
0.00%
0/59 • 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 treatment at least once.
|
2.6%
3/114 • 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 treatment at least once.
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Viral rash
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
2/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Viral pharyngitis
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/59 • 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 treatment at least once.
|
1.8%
2/114 • 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 treatment at least once.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Nervous system disorders
Somnolence
|
3.4%
2/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
5.1%
3/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/59 • 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 treatment at least once.
|
1.8%
2/114 • 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 treatment at least once.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Psychiatric disorders
Middle insomnia
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Psychiatric disorders
Restlessness
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • 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 treatment at least once.
|
3.5%
4/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • 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 treatment at least once.
|
1.8%
2/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59 • 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 treatment at least once.
|
0.88%
1/114 • 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 treatment at least once.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.7%
1/59 • 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 treatment at least once.
|
0.00%
0/114 • 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 treatment at least once.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER