Trial Outcomes & Findings for A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder (NCT NCT03737474)
NCT ID: NCT03737474
Last Updated: 2024-04-29
Results Overview
A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
248 participants
Primary outcome timeframe
From baseline to week 52
Results posted on
2024-04-29
Participant Flow
This trial was conducted in 248 participants in Japan. Of the 248 subjects who were administered investigational medicinal product, the efficacy analysis set and the safety analysis set comprised 247 subjects (216 rollover subjects, 31 newly enrolled subjects) of the total brexpiprazole population.
Participant milestones
| Measure |
New Subjects
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
216
|
|
Overall Study
COMPLETED
|
6
|
132
|
|
Overall Study
NOT COMPLETED
|
25
|
84
|
Reasons for withdrawal
| Measure |
New Subjects
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
48
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
8
|
|
Overall Study
Withdrawal by Subject
|
5
|
20
|
|
Overall Study
Non-compliance With Study Drug
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
4
|
Baseline Characteristics
A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
216 Participants
n=4 Participants
|
216 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age, Continuous
|
70.3 Years
STANDARD_DEVIATION 4.5 • n=93 Participants
|
40.7 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
44.4 Years
STANDARD_DEVIATION 13.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
133 Participants
n=4 Participants
|
146 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=93 Participants
|
216 Participants
n=4 Participants
|
247 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
31 participants
n=93 Participants
|
216 participants
n=4 Participants
|
247 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 52Population: The safety analysis set comprised subjects who have received at least 1 dose of the IMP.
A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)
|
96.8 percentage of participants
|
93.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52(LOCF)Population: The efficacy analysis set comprised subjects who have received at least 1 dose of the IMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment.
The MADRS was a clinician-rated scale which evaluated the level of depression.The MADRS consists of 10 items assessed apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Mean Changes From Baseline in Montgomery Åsberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF)
|
-2.8 Units on a scale
Standard Error 10.4
|
-4.9 Units on a scale
Standard Error 9.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment.
The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF)
|
29.0 percentage of Participants
|
37.0 percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment.
The CGI-S Scale was a clinician-rated scale which assessed how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF)
|
-0.5 units on a scale
Standard Deviation 1.3
|
-0.5 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment.
The HAM-D was a clinician-rated scale which evaluated the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item was scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF)
|
-2.2 units on a scale
Standard Deviation 8.3
|
-4.1 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment.
SDS Scale was a patient-rated scale which assessed the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10. The mean SDS score was the mean of scores for 3 items. Higher scores indicate worse condition.
Outcome measures
| Measure |
New Subjects
n=31 Participants
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 Participants
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF)
|
0.43 score on a scale
Standard Deviation 2.48
|
-0.61 score on a scale
Standard Deviation 2.35
|
Adverse Events
New Subjects
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Rollover Subjects
Serious events: 8 serious events
Other events: 201 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
New Subjects
n=31 participants at risk
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 participants at risk
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Death
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
HIV infection
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Septic shock
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Major depression
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
Other adverse events
| Measure |
New Subjects
n=31 participants at risk
Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily.
|
Rollover Subjects
n=216 participants at risk
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
9.7%
3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.1%
11/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Endocrine disorders
Primary hypogonadism
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Eye disorders
Asthenopia
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Eye disorders
Eyelid oedema
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.1%
11/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.2%
7/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.6%
12/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.6%
12/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Fatigue
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Feeling hot
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Gait disturbance
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Malaise
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
6.0%
13/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Oedema
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
General disorders
Thirst
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
6/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.2%
7/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
16.1%
5/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
21.8%
47/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Infected dermal cyst
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.2%
9/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
6/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood insulin increased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.3%
5/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood prolactin increased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.2%
9/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.7%
8/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Electrocardiogram T wave inversion
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Liver function test abnormal
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Weight decreased
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.2%
7/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Investigations
Weight increased
|
12.9%
4/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
36.1%
78/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
7.9%
17/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.4%
3/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.3%
5/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.8%
6/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Akathisia
|
38.7%
12/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
21.3%
46/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Bradykinesia
|
9.7%
3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.4%
3/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Disturbance in attention
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.2%
9/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dyskinesia
|
12.9%
4/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.2%
7/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dystonia
|
9.7%
3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.3%
5/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Extrapyramidal disorder
|
12.9%
4/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
5.6%
12/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
10.2%
22/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Parkinsonism
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
11.1%
24/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Tremor
|
19.4%
6/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
6.9%
15/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.3%
5/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.2%
9/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
10.2%
22/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
3.7%
8/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Major depression
|
9.7%
3/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
4.6%
10/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Terminal insomnia
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.46%
1/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.93%
2/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
2.3%
5/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
3.2%
1/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
0.00%
0/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
1.9%
4/216 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place