Trial Outcomes & Findings for Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome (NCT NCT00233363)
NCT ID: NCT00233363
Last Updated: 2021-06-04
Results Overview
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Weeks 2, 4, and 8
Results posted on
2021-06-04
Participant Flow
Participant milestones
| Measure |
Rebamipide
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
A placebo tablet was administered orally three times a day for eight weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
50
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Rebamipide
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
A placebo tablet was administered orally three times a day for eight weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Aggravation of complication
|
1
|
0
|
Baseline Characteristics
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Baseline characteristics by cohort
| Measure |
Rebamipide
n=50 Participants
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
n=50 Participants
A placebo tablet was administered orally three times a day for eight weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 4, and 8Population: The Efficacy Analysis Set comprised subjects in the Full Analysis Set (subjects received IMP at least once) excluding ineligible subjects and subjects with protocol deviations as described below: 1. Subjects violating the rules on concomitant therapy 2. Subjects with poor treatment compliance (\<80% of the prescribed dose at time of treatment discontinuation/completion) 3. Subjects with missing data on the primary endpoint at all time points
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Outcome measures
| Measure |
Rebamipide
n=50 Participants
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
n=50 Participants
A placebo tablet was administered orally three times a day for eight weeks.
|
|---|---|---|
|
Overall Improvement Rate in Dry Mouth Symptoms
Week 2
|
26.0 percentage of participants
Interval 13.8 to 38.2
|
20.0 percentage of participants
Interval 8.9 to 31.1
|
|
Overall Improvement Rate in Dry Mouth Symptoms
Week 4
|
44.0 percentage of participants
Interval 30.2 to 57.8
|
27.1 percentage of participants
Interval 14.5 to 39.7
|
|
Overall Improvement Rate in Dry Mouth Symptoms
Week 8
|
46.9 percentage of participants
Interval 33.0 to 60.9
|
39.1 percentage of participants
Interval 25.0 to 53.2
|
Adverse Events
Rebamipide
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rebamipide
n=53 participants at risk
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
n=51 participants at risk
A placebo tablet was administered orally three times a day for eight weeks.
|
|---|---|---|
|
Infections and infestations
Herpes zoster
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
Other adverse events
| Measure |
Rebamipide
n=53 participants at risk
A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.
|
Placebo
n=51 participants at risk
A placebo tablet was administered orally three times a day for eight weeks.
|
|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Eye disorders
Ocular hyperaemia
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Gingival pain
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
5.9%
3/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Gastrointestinal disorders
Chapped lips
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
General disorders
Chest pain
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
General disorders
Face oedema
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
General disorders
Feeling abnormal
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
General disorders
Malaise
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
General disorders
Pyrexia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Hepatobiliary disorders
Liver disorder
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Furuncle
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Herpes simplex
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Herpes virus infection
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
11.8%
6/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Parotitis
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Pharyngitis
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Rhinitis
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Blood cholesterol increased
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Blood creatinine increased
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Platelet count decreased
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Protein total increased
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
White blood cell count decreased
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
White blood cell count increased
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Urine bilirubin increased
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Investigations
Gout
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
9.8%
5/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
7.8%
4/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
2/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
3.9%
2/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
2.0%
1/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
|
Vascular disorders
Hot flush
|
1.9%
1/53 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
0.00%
0/51 • Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place