Trial Outcomes & Findings for A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder (NCT NCT03315793)
NCT ID: NCT03315793
Last Updated: 2021-01-05
Results Overview
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. 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 a higher number indicates a greater 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. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2021-01-05
Participant Flow
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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
75
|
74
|
|
Overall Study
COMPLETED
|
70
|
71
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Difficult for regular visit
|
0
|
1
|
Baseline Characteristics
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine
n=74 Participants
20 mg Duloxetine was administered 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 4 weeks. Lower doses Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
65.7 units on a scale
STANDARD_DEVIATION 10.5 • n=5 Participants
|
63.3 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
|
64.5 units on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received 1 dose of study drug and had 1 post-baseline CDRS-S score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis.
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. 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 a higher number indicates a greater 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. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.
Outcome measures
| Measure |
Duloxetine
n=74 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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
-21.03 units on a scale
Standard Error 2.04
|
-22.42 units on a scale
Standard Error 2.05
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used.
The 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 greater 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=74 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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline
|
48.6 percentage of participants
|
43.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used.
The 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 with higher numbers indicating a greater degree of depression . The total sum of scores range from 17 to 113. 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=74 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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline
|
21.6 percentage of participants
|
21.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used.
The 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 greater 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. Remission was defined for the CDRS-R total score below 28.
Outcome measures
| Measure |
Duloxetine
n=74 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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28
|
9.5 percentage of participants
|
13.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose CDRS-R Total score. One duloxetine participant had no post-dose CDRS-R Total Score and was not included in the analysis.
CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Presented here are the LS mean change from baseline on CGI-S calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CGI-S and age as covariates.
Outcome measures
| Measure |
Duloxetine
n=74 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 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 Participants
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Change From Baseline on Clinical Global Impression-Severity (CGI-S)
|
-1.24 units on a scale
Standard Error 0.14
|
-1.38 units on a scale
Standard Error 0.14
|
Adverse Events
Duloxetine
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duloxetine
n=75 participants at risk
20 mg Duloxetine was administered 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 4 weeks.
Lower doses of Duloxetine were administered for 1 week during tapering off period.
|
Placebo
n=74 participants at risk
Placebo was administered every day for 7 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
6.7%
5/75 • Number of events 5 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
9.3%
7/75 • Number of events 7 • Baseline to 7 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.
|
2.7%
2/74 • Number of events 2 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
25.3%
19/75 • Number of events 20 • Baseline to 7 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.
|
12.2%
9/74 • Number of events 10 • Baseline to 7 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%
3/75 • Number of events 3 • Baseline to 7 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.
|
5.4%
4/74 • Number of events 4 • Baseline to 7 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
Asthenia
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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 hot
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
6.7%
5/75 • Number of events 5 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Pain
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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%
2/75 • Number of events 2 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Vaccination site swelling
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
Hand-foot-and-mouth disease
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
Laryngitis
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
13.3%
10/75 • Number of events 10 • Baseline to 7 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.
|
16.2%
12/74 • Number of events 12 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
2.7%
2/74 • Number of events 2 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
Chillblains
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Alanine aminotransferase increased
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
17.3%
13/75 • Number of events 13 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
4.0%
3/75 • Number of events 3 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Head discomfort
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
8.0%
6/75 • Number of events 6 • Baseline to 7 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.
|
10.8%
8/74 • Number of events 9 • Baseline to 7 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%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
22.7%
17/75 • Number of events 17 • Baseline to 7 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.
|
10.8%
8/74 • Number of events 8 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Aggression
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
Euphoric mood
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Initial insomnia
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
4.0%
3/75 • Number of events 5 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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%
1/75 • Number of events 1 • Baseline to 7 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.
|
2.7%
2/74 • Number of events 2 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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.
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
3.4%
1/29 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/27 • Baseline to 7 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
|
0.00%
0/46 • Baseline to 7 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.
|
2.1%
1/47 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
2.7%
2/74 • Number of events 2 • Baseline to 7 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
Yawning
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
0.00%
0/75 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
1.4%
1/74 • Number of events 1 • Baseline to 7 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 thermal
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Hot flush
|
1.3%
1/75 • Number of events 1 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
|
2.7%
2/75 • Number of events 2 • Baseline to 7 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.
|
0.00%
0/74 • Baseline to 7 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
Restriction type: GT60