Trial Outcomes & Findings for A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer (NCT NCT03553563)
NCT ID: NCT03553563
Last Updated: 2026-03-04
Results Overview
Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
8 to 32 weeks
Results posted on
2026-03-04
Participant Flow
First participant enrolled on 24 July 2018 Last participant last visit on 27 December 2022. This study was conducted at a total of 17 sites in Japan.
In this study, in total 53 participants completed the informed consent process. Out of the 53 participants, 3 participants could not start the study treatment. In total, 50 participants were enrolled in this study and started the study treatment.
Participant milestones
| Measure |
Group 1
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
Group 3
Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight\<20 kg
|
Group 4
Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight\>=20 kg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
21
|
9
|
13
|
|
Overall Study
COMPLETED
|
6
|
18
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
Group 3
Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight\<20 kg
|
Group 4
Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight\>=20 kg
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
Baseline characteristics by cohort
| Measure |
Group 1
n=7 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=21 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
Group 3
n=9 Participants
Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight\<20 kg
|
Group 4
n=13 Participants
Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight\>=20 kg
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
3.7 Years
STANDARD_DEVIATION 1.7 • n=41 Participants
|
10.3 Years
STANDARD_DEVIATION 2.2 • n=35 Participants
|
5.2 Years
STANDARD_DEVIATION 2.1 • n=76 Participants
|
11.3 Years
STANDARD_DEVIATION 2.4 • n=565 Participants
|
8.7 Years
STANDARD_DEVIATION 3.7 • n=196 Participants
|
|
Age, Customized
<=3 years old
|
4 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
6 Participants
n=196 Participants
|
|
Age, Customized
4 - 5 years old
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
4 Participants
n=196 Participants
|
|
Age, Customized
6 - 7 years old
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
8 Participants
n=196 Participants
|
|
Age, Customized
8 - 9 years old
|
0 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
10 Participants
n=196 Participants
|
|
Age, Customized
10 - 11 years old
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
5 Participants
n=565 Participants
|
9 Participants
n=196 Participants
|
|
Age, Customized
12 -14 years old
|
0 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
6 Participants
n=565 Participants
|
13 Participants
n=196 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
7 Participants
n=565 Participants
|
18 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
6 Participants
n=565 Participants
|
32 Participants
n=196 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
9 Participants
n=76 Participants
|
13 Participants
n=565 Participants
|
50 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=196 Participants
|
PRIMARY outcome
Timeframe: 8 to 32 weeksPopulation: Out of the 21 participatns in Group 2, two participants were excluded from the summary of this outcome measure. one participant discontinued the study prior to 8 weeks after the start. The other participant was not fulfilled with the inclusion criteria for the efficacy analysis set.
Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Outcome measures
| Measure |
Group 1
n=7 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=19 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Presence/Absence of Reflux Esophagitis Relapse
Presence of reflux esophagitis relapse
|
0 Participants
|
1 Participants
|
|
Presence/Absence of Reflux Esophagitis Relapse
Absence of reflux esophagitis relapse
|
7 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 0 to 32 weeksPrevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Outcome measures
| Measure |
Group 1
n=9 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=13 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Presence of gastric ulcer or duodenal ulcer recurrence
|
1 Participants
|
0 Participants
|
|
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Absence of gastric ulcer or duodenal ulcer recurrence
|
8 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 8 to 32 weeksPopulation: Out of the 21 participatns in Group 2, one participant was excluded from the summary of this outcome measure. This participant discontinued the study prior to 8 weeks after the start.
Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Outcome measures
| Measure |
Group 1
n=7 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=20 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Adverse Events During Reflux Esophagitis Maintenance Therapy
|
7 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 0 to 32 weeksPrevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Outcome measures
| Measure |
Group 1
n=9 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=13 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 8 to 52 weeksPopulation: Only participants who continued the study treatment after Week 32 were included in this secondary analysis.
Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Outcome measures
| Measure |
Group 1
n=6 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=16 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Presence/Absence of Reflux Esophagitis Relapse
Presence of reflux esophagitis relapse
|
1 Participants
|
4 Participants
|
|
Presence/Absence of Reflux Esophagitis Relapse
Absence of reflux esophagitis relapse
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 0 to 52 weeksPopulation: Only participants who continued the study treatment after Week 32 were included in this secondary analysis.
Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Outcome measures
| Measure |
Group 1
n=6 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=7 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Presence of gastric ulcer or duodenal ulcer recurrence
|
1 Participants
|
0 Participants
|
|
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Absence of gastric ulcer or duodenal ulcer recurrence
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 8 to 52 weeksPopulation: Only participants who continued the study treatment after Week 32 were included in this secondary analysis.
Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event during the period
Outcome measures
| Measure |
Group 1
n=6 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=16 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Adverse Events During Reflux Esophagitis Maintenance Therapy
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 0 to 52 weeksPopulation: Only participants who continued the study treatment after Week 32 were included in this secondary analysis.
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event
Outcome measures
| Measure |
Group 1
n=6 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=7 Participants
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
|---|---|---|
|
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
|
6 Participants
|
6 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 3
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 4
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=7 participants at risk
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=21 participants at risk
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
Group 3
n=9 participants at risk
Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight\<20 kg
|
Group 4
n=13 participants at risk
Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight\>=20 kg
|
|---|---|---|---|---|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Vascular disorders
Polyarteritis nodosa
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Chronic recurrent multifocal osteomyelitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Congenital, familial and genetic disorders
Pulmonary artery atresia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
Other adverse events
| Measure |
Group 1
n=7 participants at risk
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight\<20 kg
|
Group 2
n=21 participants at risk
Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight\>=20 kg
|
Group 3
n=9 participants at risk
Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight\<20 kg
|
Group 4
n=13 participants at risk
Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight\>=20 kg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Ear and labyrinth disorders
Motion sickness
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Eye disorders
Accommodation disorder
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Eye disorders
Conjunctivitis allergic
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
14.3%
3/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
23.8%
5/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Enterocolitis
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Immune system disorders
Food allergy
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Acute haemorrhagic conjunctivitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Bronchitis
|
28.6%
2/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Bronchitis mycoplasmal
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Conjunctivitis
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Erythema infectiosum
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Gastroenteritis
|
28.6%
2/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
28.6%
6/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
33.3%
3/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Herpangina
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Influenza
|
42.9%
3/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
23.1%
3/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Molluscum contagiosum
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Nasopharyngitis
|
85.7%
6/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
28.6%
6/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
30.8%
4/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Pharyngitis
|
42.9%
3/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
23.1%
3/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Skin candida
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Varicella
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
28.6%
2/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Injury, poisoning and procedural complications
Wound
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Chronic recurrent multifocal osteomyelitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
4.8%
1/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
11.1%
1/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
9.5%
2/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
22.2%
2/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
7.7%
1/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
|
Vascular disorders
Haematoma
|
14.3%
1/7 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/21 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/9 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
0.00%
0/13 • Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
All collected serious adverse events and other adverse events were summarized by groups.
|
Additional Information
Masahiro Nii/Japan project statistician
Biometrics & Real World Analytics Department, AstraZeneca Japan
Phone: +817022748322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place