Trial Outcomes & Findings for A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases (NCT NCT02153398)
NCT ID: NCT02153398
Last Updated: 2017-01-19
Results Overview
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-01-19
Participant Flow
First subject enrolled on 24 June 2014 Last subject last visit on 04 April 2016. This study was conducted at a total of 20 sites in Japan.
Out of 55 enrolled subjects, 50 subjects were registered and 5 subjects were not registered. The reason of no registration was 'Did not meet inclusion/exclusion criteria' (5 subjects).
Participant milestones
| Measure |
Group 1
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Baseline characteristics by cohort
| Measure |
Group 1
n=10 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=10 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
3.6 Years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.9 Years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
8.4 Years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
13.4 Years
STANDARD_DEVIATION 0.7 • n=4 Participants
|
13.1 Years
STANDARD_DEVIATION 0.9 • n=21 Participants
|
9.5 Years
STANDARD_DEVIATION 3.9 • n=10 Participants
|
|
Age, Customized
<= 3 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Customized
4-5 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
6-7 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Age, Customized
8-9 years
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Age, Customized
10-11 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Customized
12-14 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Outcome measures
| Measure |
Group 1
n=2 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=3 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=1 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=1 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=4 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Heartburn at Week 8 by Patient Diaries
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.
The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Outcome measures
| Measure |
Group 1
n=2 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=6 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=4 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=7 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.
The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Outcome measures
| Measure |
Group 1
n=3 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=6 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=4 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=6 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.
The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Outcome measures
| Measure |
Group 1
n=4 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=3 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=3 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=4 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Regurgitation at Week 8 by Patient Diaries
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.
The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=7 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=8 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=8 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=6 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Heartburn at Week 8 by Patient Diaries
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.
The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=4 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=5 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=3 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.
The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Outcome measures
| Measure |
Group 1
n=6 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=4 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=5 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=4 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.
The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Outcome measures
| Measure |
Group 1
n=5 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=7 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=6 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=6 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Regurgitation at Week 8 by Patient Diaries
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=2 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=2 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=2 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=3 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Heartburn at Week 8 by Investigators
|
2 Participants
|
1 Participants
|
—
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=2 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=6 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=7 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=9 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Epigastric Pain at Week 8 by Investigators
|
2 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=3 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=6 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=7 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=6 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=4 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=1 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=1 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=3 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Disappearance of Regurgitation at Week 8 by Investigators
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=8 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=9 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=7 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=7 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Heartburn at Week 8 by Investigators
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=4 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=5 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=2 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=1 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Epigastric Pain at Week 8 by Investigators
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=6 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=4 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=2 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=4 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Outcome measures
| Measure |
Group 1
n=5 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=9 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=4 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=8 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=7 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Aggravation of Regurgitation at Week 8 by Investigators
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=9 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
|
7.04 μmol*h/L
Standard Deviation 3.05
|
3.52 μmol*h/L
Standard Deviation 2.35
|
11.05 μmol*h/L
Standard Deviation 5.11
|
2.38 μmol*h/L
Standard Deviation 1.74
|
5.82 μmol*h/L
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=9 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
|
5.53 μmol*h/L
Standard Deviation 3.69
|
3.09 μmol*h/L
Standard Deviation 2.34
|
10.41 μmol*h/L
Standard Deviation 4.55
|
1.99 μmol*h/L
Standard Deviation 1.30
|
5.45 μmol*h/L
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=9 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
|
3.42 μmol/L
Standard Deviation 2.09
|
2.09 μmol/L
Standard Deviation 1.53
|
5.91 μmol/L
Standard Deviation 2.19
|
1.09 μmol/L
Standard Deviation 0.57
|
3.13 μmol/L
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=9 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
|
1.58 hour
Full Range 2.09 • Interval 1.03 to 5.92
|
1.52 hour
Full Range 1.53 • Interval 0.92 to 6.0
|
1.47 hour
Full Range 2.19 • Interval 0.93 to 1.52
|
1.57 hour
Full Range 0.57 • Interval 0.93 to 2.95
|
1.75 hour
Full Range 1.36 • Interval 0.95 to 3.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=9 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
|
0.80 hour
Standard Deviation 0.18
|
0.97 hour
Standard Deviation 0.55
|
1.08 hour
Standard Deviation 0.44
|
1.37 hour
Standard Deviation 0.88
|
1.06 hour
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=9 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
|
4.74 L/h
Standard Deviation 1.92
|
12.44 L/h
Standard Deviation 8.90
|
6.44 L/h
Standard Deviation 3.37
|
23.33 L/h
Standard Deviation 24.93
|
10.94 L/h
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dosePopulation: All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Outcome measures
| Measure |
Group 1
n=7 Participants
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=9 Participants
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 Participants
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=9 Participants
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 Participants
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
|
5.10 L
Standard Deviation 1.24
|
16.56 L
Standard Deviation 16.21
|
9.21 L
Standard Deviation 4.00
|
44.73 L
Standard Deviation 72.03
|
15.90 L
Standard Deviation 4.42
|
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 5
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=10 participants at risk
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 participants at risk
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 participants at risk
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=10 participants at risk
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 participants at risk
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
10.0%
1/10 • Number of events 1 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Number of events 1 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Number of events 1 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
Other adverse events
| Measure |
Group 1
n=10 participants at risk
D961H sachet 10 mg Age: 1-11 years and Weight: \<20 kg
|
Group 2
n=10 participants at risk
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 3
n=10 participants at risk
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
|
Group 4
n=10 participants at risk
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
|
Group 5
n=10 participants at risk
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Mumps
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
40.0%
4/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
30.0%
3/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Pneumonia
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Streptococcal infection
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Varicella
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Eye disorders
Hordeolum
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
10.0%
1/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
0.00%
0/10 • Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
During the administration period, the investigator/clinical research coordinator contacted the patient or patients' guardian (e.g. by phone) at least once in every week to confirm patient's health condition and compliance of study drug.
|
Additional Information
Masahiro Nii
Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AstraZeneca approval before this study was completed.
- Publication restrictions are in place
Restriction type: OTHER