Trial Outcomes & Findings for A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder (NCT NCT03395353)
NCT ID: NCT03395353
Last Updated: 2021-06-18
Results Overview
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
Baseline through Week 53
Results posted on
2021-06-18
Participant Flow
59 and 64 subjects, respectively, were enrolled consecutively from the placebo- and duloxetine-group in the preceding study 1701A3631/F1J-JE-B058, NCT03315793. 28 new participants were also enrolled.
Participant milestones
| Measure |
Duloxetine
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
150
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
87
|
Reasons for withdrawal
| Measure |
Duloxetine
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
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|---|---|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
24
|
|
Overall Study
Discontinued visit
|
1
|
|
Overall Study
Refrain from visit due to COVID-19
|
1
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Early termination of overall study
|
33
|
Baseline Characteristics
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine
n=150 Participants
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 53Population: All enrolled participants who received at least one dose of study drug.
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
Outcome measures
| Measure |
Duloxetine
n=150 Participants
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
Duloxetine 40 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 40mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (9 to 11 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
Serious Adverse Event
|
2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
Adverse Event including Serious Adverse Event
|
89.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
Drug-Related Adverse Event
|
73.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total score. Missing values due to discontinuation of study or missing data were imputed using last observation carried forward (LOCF).
Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a higher degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.
Outcome measures
| Measure |
Duloxetine
n=150 Participants
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
Duloxetine 40 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 40mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (9 to 11 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
|---|---|---|---|---|
|
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
|
-12.8 units on a scale
Standard Deviation 16.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total score. Missing values due to discontinuation of study or missing data were imputed using last observation carried forward (LOCF).
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Outcome measures
| Measure |
Duloxetine
n=150 Participants
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
Duloxetine 40 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 40mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (9 to 11 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (12 to 17 Years Old)
Trough concentrations of duloxetine 60mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
|---|---|---|---|---|
|
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
|
-0.9 units on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 through Week 50Population: All enrolled participants who received at least 1 dose of study drug. 512 plasma concentrations were from 141 subjects, 20 of which were excluded due to discontinuation, overdose and subjects being non-Japanese. 492 concentration values from 136 Japanese subjects were included in the analysis. Of the 492 concentration values, 133 from 106 subjects were trough concentrations. Sum of subjects(3, 47, 6, 54) is 110, 4 more than 106, as 4 subjects of 12-17 years old are redundant in 40mg and 60mg.
Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations.
Outcome measures
| Measure |
Duloxetine
n=4 Trough Concentration
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
Duloxetine 40 mg (12 to 17 Years Old)
n=52 Trough Concentration
Trough concentrations of duloxetine 40mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (9 to 11 Years Old)
n=7 Trough Concentration
Trough concentrations of duloxetine 60mg were obtained from 9 to 11 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
Duloxetine 60 mg (12 to 17 Years Old)
n=70 Trough Concentration
Trough concentrations of duloxetine 60mg were obtained from 12 to 17 year olds. Trough concentrations are defined as the plasma concentrations 18 to 30 hours after the last administration of duloxetine.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Trough Concentration of Duloxetine
|
8.51 ng/mL
Standard Deviation 7.22
|
18 ng/mL
Standard Deviation 15.2
|
33.4 ng/mL
Standard Deviation 30.7
|
39.5 ng/mL
Standard Deviation 52.1
|
Adverse Events
Duloxetine
Serious events: 3 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine
n=150 participants at risk
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
|---|---|
|
Psychiatric disorders
Abnormal behaviour
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mania
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Duloxetine
n=150 participants at risk
20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.67%
1/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Blepharitis allergic
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Myopia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
30.7%
46/150 • Number of events 56 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
9/150 • Number of events 9 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
8/150 • Number of events 8 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
8/150 • Number of events 9 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
7/150 • Number of events 8 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
7/150 • Number of events 9 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
6/150 • Number of events 8 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal fissure
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip dry
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Melaena
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
5.3%
8/150 • Number of events 8 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Withdrawal syndrome
|
3.3%
5/150 • Number of events 5 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Thirst
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Anovulatory cycle
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
6/150 • Number of events 7 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
50/150 • Number of events 64 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
5/150 • Number of events 5 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dermatitis infected
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Skin bacterial infection
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Malassezia infection
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Streptococcal infection
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Purulence
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Chilblains
|
0.67%
1/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ear canal abrasion
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
2.0%
3/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
2.0%
3/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Liver function test increased
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure decreased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood triglycerides increased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haematocrit decreased
|
0.67%
1/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein total decreased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count increased
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
3/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
28.0%
42/150 • Number of events 48 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
13.3%
20/150 • Number of events 25 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
11.3%
17/150 • Number of events 18 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
3.3%
5/150 • Number of events 5 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Akathisia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Restless legs syndrome
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Irregular sleep wake rhythm disorder
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Intentional self-injury
|
12.0%
18/150 • Number of events 23 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep disorder
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Irritability
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Agitation
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Mania
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Middle insomnia
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Neurosis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Nightmare
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Restlessness
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Trichotillomania
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Affect lability
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Colour blindness
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.3%
2/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.0%
6/150 • Number of events 7 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.7%
4/150 • Number of events 4 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
2/150 • Number of events 2 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.67%
1/150 • Number of events 1 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
2.0%
3/150 • Number of events 3 • Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place