Trial Outcomes & Findings for Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) (NCT NCT03149445)
NCT ID: NCT03149445
Last Updated: 2024-02-26
Results Overview
Percent change from baseline to end of treatment in mean body weight. LOCF.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Results posted on
2024-02-26
Participant Flow
Participant milestones
| Measure |
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Double-blind (DB) Step 1
STARTED
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind (DB) Step 1
COMPLETED
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind (DB) Step 1
NOT COMPLETED
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind (DB) Step 2
STARTED
|
0
|
0
|
5
|
4
|
0
|
0
|
0
|
0
|
|
Double-blind (DB) Step 2
COMPLETED
|
0
|
0
|
5
|
4
|
0
|
0
|
0
|
0
|
|
Double-blind (DB) Step 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open Label Extension (OLE) I
STARTED
|
0
|
0
|
0
|
0
|
4
|
4
|
0
|
0
|
|
Open Label Extension (OLE) I
COMPLETED
|
0
|
0
|
0
|
0
|
4
|
3
|
0
|
0
|
|
Open Label Extension (OLE) I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open Label Extension (OLE) II
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
|
Open Label Extension (OLE) II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Open Label Extension (OLE) II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
Baseline characteristics by cohort
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=7 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
5 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
4 Participants
n=4 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
9 Participants
n=21 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
3 Participants
n=7 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=4 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
9 Participants
n=21 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=7 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=5 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=4 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
0 Participants
n=21 Participants • It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Percent change from baseline to end of treatment in mean body weight. LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to End of Treatment in Mean Body Weight
|
-4.09 Percent (%) change in mean body weight
Standard Deviation 3.73
|
-0.38 Percent (%) change in mean body weight
Standard Deviation 2.05
|
3.56 Percent (%) change in mean body weight
Standard Deviation 2.73
|
3.00 Percent (%) change in mean body weight
Standard Deviation 2.35
|
5.79 Percent (%) change in mean body weight
Standard Deviation 2.08
|
0.33 Percent (%) change in mean body weight
Standard Deviation 3.26
|
-1.20 Percent (%) change in mean body weight
Standard Deviation 3.80
|
-5.51 Percent (%) change in mean body weight
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in body weight \[kg\]. LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Mean Body Weight
|
-4.15 kg
Standard Deviation 4.82
|
-0.77 kg
Standard Deviation 3.23
|
3.10 kg
Standard Deviation 2.85
|
2.25 kg
Standard Deviation 1.71
|
4.75 kg
Standard Deviation 2.41
|
0.45 kg
Standard Deviation 2.82
|
-0.90 kg
Standard Deviation 3.20
|
-3.50 kg
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 2 patients in Step I placebo arm. 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in HQ-CT score. LOCF. HQ-CT score was based upon a questionnaire with 9 items, each of them yielding a score between 0 and 4 resulting in a maximum HQ-CT score of 36. Change in HQ-CT answers (by question and in total) calculated as score at visit 2, 5, 9 or 14 minus score at screening visit 1 was analysed and presented using standard descriptive statistics (mean, median, standard deviation, minimum and maximum value). A decrease in total score indicates an improvement in hyperphagia. If less than three questions were answered by a subject, the missing answers were imputed by the mean score of all other available answers. In case of more than three missing answers, the total score was not calculated. For further information please refer to protocol appendix section 17.1.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=2 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
|
-8.50 score on a scale
Standard Deviation 9.25
|
-4.00 score on a scale
Standard Deviation 7.07
|
-3.30 score on a scale
Standard Deviation 6.82
|
-6.75 score on a scale
Standard Deviation 3.69
|
1.25 score on a scale
Standard Deviation 5.68
|
-1.75 score on a scale
Standard Deviation 1.50
|
-1.00 score on a scale
Standard Deviation 2.00
|
-2.00 score on a scale
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 29; DB Step 2: Day 29; OLE I: Day 120; OLE II: Day 210Population: No data available for placebo arm in Step I and Step 2. Data only available for 3 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Steady state concentrations of tesofensine and metoprolol as measured by trough values. Observed values.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
Tesofensine
|
16.29 μg/L
Geometric Coefficient of Variation 49.8
|
—
|
3.34 μg/L
Geometric Coefficient of Variation 32.2
|
—
|
4.14 μg/L
Geometric Coefficient of Variation 17.3
|
5.06 μg/L
Geometric Coefficient of Variation 18.0
|
4.13 μg/L
Geometric Coefficient of Variation 137.5
|
6.43 μg/L
Geometric Coefficient of Variation NA
Only 1 subject was included in this group.
|
|
Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
Teso. metab.
|
2.97 μg/L
Geometric Coefficient of Variation 52.6
|
—
|
0.79 μg/L
Geometric Coefficient of Variation 17.1
|
—
|
1.45 μg/L
Geometric Coefficient of Variation 23.3
|
1.00 μg/L
Geometric Coefficient of Variation 41.9
|
1.56 μg/L
Geometric Coefficient of Variation 49.1
|
1.98 μg/L
Geometric Coefficient of Variation NA
Only 1 subject was included in this group.
|
|
Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
Metoprolol
|
1.61 μg/L
Geometric Coefficient of Variation 903.7
|
—
|
1.97 μg/L
Geometric Coefficient of Variation 285.5
|
—
|
2.81 μg/L
Geometric Coefficient of Variation 119.0
|
3.32 μg/L
Geometric Coefficient of Variation 32.0
|
1.76 μg/L
Geometric Coefficient of Variation 242.5
|
14.50 μg/L
Geometric Coefficient of Variation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Change from baseline to end of treatment in fat- and fat free mass (%) by dual X-ray absorptiometry (DEXA). Observed values.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=3 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=3 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=2 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=2 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=2 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Fat- and Fat Free Mass (%) by Dual X-ray Absorptiometry (DEXA)
Fat free mass
|
1.19 Percent (%)
Standard Deviation 1.11
|
—
|
0.137 Percent (%)
Standard Deviation 0.217
|
-2.080 Percent (%)
Standard Deviation 4.511
|
0.053 Percent (%)
Standard Deviation 2.559
|
4.290 Percent (%)
Standard Deviation 3.974
|
0.000 Percent (%)
Standard Deviation 0.1
|
1.470 Percent (%)
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Fat- and Fat Free Mass (%) by Dual X-ray Absorptiometry (DEXA)
Fat mass
|
-1.27 Percent (%)
Standard Deviation 1.07
|
—
|
-0.13 Percent (%)
Standard Deviation 0.25
|
-0.50 Percent (%)
Standard Deviation 0.85
|
1.20 Percent (%)
Standard Deviation 1.74
|
-0.05 Percent (%)
Standard Deviation 0.21
|
-1.70 Percent (%)
Standard Deviation 0.1
|
-1.50 Percent (%)
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Change from baseline to end of treatment in BMD by dual X-ray absorptiometry (DEXA). Observed values.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=3 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=3 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=2 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=2 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=2 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Bone Mineral Density (BMD) by Dual X-ray Absorptiometry (DEXA)
|
0.002 g/cm^2
Standard Deviation 0.0017
|
—
|
0.019 g/cm^2
Standard Deviation 0.009
|
0.035 g/cm^2
Standard Deviation 0.008
|
-0.006 g/cm^2
Standard Deviation 0.008
|
-0.007 g/cm^2
Standard Deviation 0.009
|
0.023 g/cm^2
Standard Deviation 0.0
|
0.009 g/cm^2
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Change from baseline to end of treatment in BMC by dual X-ray absorptiometry (DEXA). Observed values.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=3 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=3 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=2 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=2 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=2 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Bone Mineral Content (BMC) by Dual X-ray Absorptiometry (DEXA)
|
9.5 gram
Standard Deviation 63.8
|
—
|
74.77 gram
Standard Deviation 22.46
|
35.53 gram
Standard Deviation 55.37
|
-1.12 gram
Standard Deviation 17.86
|
5.69 gram
Standard Deviation 66.33
|
22.51 gram
Standard Deviation 46.6
|
-21.90 gram
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in HR (bpm). LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Heart Rate (HR)
|
8.22 bpm
Standard Deviation 4.26
|
7.89 bpm
Standard Deviation 7.88
|
5.87 bpm
Standard Deviation 11.01
|
2.75 bpm
Standard Deviation 8.96
|
2.42 bpm
Standard Deviation 15.14
|
0.33 bpm
Standard Deviation 8.65
|
-9.50 bpm
Standard Deviation 10.86
|
-5.67 bpm
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in SBP (mmHg) and DBP (mmHg). LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in SBP
|
-2.72 mmHg
Standard Deviation 9.96
|
0.11 mmHg
Standard Deviation 15.22
|
-0.13 mmHg
Standard Deviation 15.79
|
-5.00 mmHg
Standard Deviation 9.26
|
5.67 mmHg
Standard Deviation 11.30
|
8.08 mmHg
Standard Deviation 6.45
|
-5.33 mmHg
Standard Deviation 2.60
|
-9.67 mmHg
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in DBP
|
0.94 mmHg
Standard Deviation 10.72
|
-8.89 mmHg
Standard Deviation 8.00
|
-1.07 mmHg
Standard Deviation 7.06
|
0.33 mmHg
Standard Deviation 2.54
|
2.92 mmHg
Standard Deviation 10.22
|
4.00 mmHg
Standard Deviation 5.40
|
-6.42 mmHg
Standard Deviation 3.95
|
1.33 mmHg
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Total number of Adverse Events
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=5 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Total Number of Adverse Events
|
23 Total number of adverse events
|
10 Total number of adverse events
|
19 Total number of adverse events
|
9 Total number of adverse events
|
11 Total number of adverse events
|
12 Total number of adverse events
|
14 Total number of adverse events
|
5 Total number of adverse events
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 1 patient in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 1 patient in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 1 patient in OLE I (Tesomet 0.125/25 mg -\> Tesomet 0.125/25 mg). Data only available for 1 patient in OLE I (Placebo -\> Tesomet 0.125/25 mg). Data not available for OLE II (Tesomet 0.25/25 mg).
Change from baseline to end of treatment in PR interval. Observed values.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=1 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=1 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=2 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=1 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=1 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in PR Interval
|
-20.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
—
|
0.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
20.0 ms
Standard Deviation 0.0
|
0.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
-20.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
—
|
10.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Change from baseline to end of treatment in ECG parameters - QRS duration, QT interval, QTcF and QTcB
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=2 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=2 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=4 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=2 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
QRS duration
|
-4.0 ms
Standard Deviation 8.5
|
4.0 ms
Standard Deviation 0.0
|
2.0 ms
Standard Deviation 2.3
|
2.0 ms
Standard Deviation 8.5
|
-1.5 ms
Standard Deviation 3.0
|
0.7 ms
Standard Deviation 5.0
|
-4.0 ms
Standard Deviation 5.7
|
0.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
QT interval
|
-7.0 ms
Standard Deviation 18.4
|
19.0 ms
Standard Deviation 9.9
|
-5.5 ms
Standard Deviation 27.2
|
5.5 ms
Standard Deviation 27.2
|
-5.0 ms
Standard Deviation 19.2
|
-13.3 ms
Standard Deviation 16.2
|
7.0 ms
Standard Deviation 7.1
|
-20.0 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
QTcF
|
-12.9 ms
Standard Deviation 4.4
|
12.8 ms
Standard Deviation 19.8
|
0.1 ms
Standard Deviation 24.4
|
11.0 ms
Standard Deviation 20.4
|
-3.7 ms
Standard Deviation 14.5
|
-10.3 ms
Standard Deviation 29.3
|
17.1 ms
Standard Deviation 4.5
|
-2.9 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
QTcB
|
-16.0 ms
Standard Deviation 2.8
|
9.0 ms
Standard Deviation 25.5
|
3.5 ms
Standard Deviation 31.8
|
13.9 ms
Standard Deviation 21.4
|
-2.6 ms
Standard Deviation 22.8
|
-8.2 ms
Standard Deviation 37.3
|
23.0 ms
Standard Deviation 2.9
|
8.2 ms
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in HbA1c (%). LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=2 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in HbA1c
|
0.11 Percentage of HbA1c
Standard Deviation 0.13
|
0.15 Percentage of HbA1c
Standard Deviation 0.21
|
0.06 Percentage of HbA1c
Standard Deviation 0.05
|
0.15 Percentage of HbA1c
Standard Deviation 0.24
|
0.12 Percentage of HbA1c
Standard Deviation 0.26
|
0.10 Percentage of HbA1c
Standard Deviation 0.17
|
0.00 Percentage of HbA1c
Standard Deviation 0.12
|
0.00 Percentage of HbA1c
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in insulin (mIU/L). LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=2 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Insulin
|
2.67 mIU/L
Standard Deviation 10.93
|
1.50 mIU/L
Standard Deviation 10.61
|
1.95 mIU/L
Standard Deviation 13.85
|
-10.32 mIU/L
Standard Deviation 17.20
|
13.14 mIU/L
Standard Deviation 22.15
|
4.93 mIU/L
Standard Deviation 5.25
|
-1.35 mIU/L
Standard Deviation 24.56
|
-5.90 mIU/L
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Population: Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -\> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Change from baseline to end of treatment in fasting pl. glucose (mmol/L), triglycerides (mmol/L), LDL and HDL cholesterol (mmol/L). LOCF.
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=2 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=3 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=4 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
Fasting pl. glucose
|
0.27 mmol/L
Standard Deviation 0.59
|
0.30 mmol/L
Standard Deviation 0.14
|
-0.20 mmol/L
Standard Deviation 0.58
|
-0.30 mmol/L
Standard Deviation 0.29
|
1.07 mmol/L
Standard Deviation 1.19
|
0.37 mmol/L
Standard Deviation 0.31
|
0.60 mmol/L
Standard Deviation 0.35
|
-0.40 mmol/L
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
Triglycerides
|
-0.07 mmol/L
Standard Deviation 0.29
|
-0.02 mmol/L
Standard Deviation 0.06
|
0.56 mmol/L
Standard Deviation 1.32
|
-1.33 mmol/L
Standard Deviation 1.54
|
-0.54 mmol/L
Standard Deviation 1.23
|
0.38 mmol/L
Standard Deviation 0.14
|
-0.13 mmol/L
Standard Deviation 0.26
|
0.13 mmol/L
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
LDL cholesterol
|
-0.16 mmol/L
Standard Deviation 0.44
|
-0.12 mmol/L
Standard Deviation 0.32
|
0.16 mmol/L
Standard Deviation 0.21
|
-0.32 mmol/L
Standard Deviation 0.99
|
-0.02 mmol/L
Standard Deviation 0.43
|
-0.01 mmol/L
Standard Deviation 0.43
|
0.10 mmol/L
Standard Deviation 0.32
|
-0.25 mmol/L
Standard Deviation NA
Only 1 subject was included in this group.
|
|
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
HDL cholesterol
|
-0.10 mmol/L
Standard Deviation 0.20
|
-0.17 mmol/L
Standard Deviation 0.01
|
-0.03 mmol/L
Standard Deviation 0.18
|
-0.03 mmol/L
Standard Deviation 0.17
|
0.16 mmol/L
Standard Deviation 0.22
|
0.22 mmol/L
Standard Deviation 0.11
|
-0.05 mmol/L
Standard Deviation 0.05
|
-0.14 mmol/L
Standard Deviation NA
Only 1 subject was included in this group.
|
SECONDARY outcome
Timeframe: DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271Number of subjects with Adverse Events and Serious Adverse Events
Outcome measures
| Measure |
Tesomet 0.50/50 mg
n=6 Participants
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 Participants
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 Participants
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 Participants
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 Participants
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=5 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 Participants
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Subjects with at least one AE
|
6 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Subjects with at least one SAE
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Tesomet 0.50/50 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (Adult)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tesomet 0.125/25 mg (DB)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Adolescent)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo -> Tesomet 0.125/25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Tesomet 0.25/25 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Tesomet 0.125/25 mg (OLE II)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tesomet 0.50/50 mg
n=6 participants at risk
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 participants at risk
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 participants at risk
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 participants at risk
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 participants at risk
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 participants at risk
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=5 participants at risk
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 participants at risk
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anger
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Hallucination
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Abnormal behaviour
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
Other adverse events
| Measure |
Tesomet 0.50/50 mg
n=6 participants at risk
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
|
Placebo (Adult)
n=3 participants at risk
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
|
Tesomet 0.125/25 mg (DB)
n=5 participants at risk
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
|
Placebo (Adolescent)
n=4 participants at risk
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
|
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
n=4 participants at risk
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Placebo -> Tesomet 0.125/25 mg
n=4 participants at risk
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
|
Tesomet 0.25/25 mg
n=5 participants at risk
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
|
Tesomet 0.125/25 mg (OLE II)
n=1 participants at risk
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
100.0%
1/1 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
General disorders
Feeling cold
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
66.7%
2/3 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
40.0%
2/5 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
100.0%
1/1 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • Number of events 3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
40.0%
2/5 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
100.0%
1/1 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Affect lability
|
33.3%
2/6 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Aggression
|
16.7%
1/6 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
100.0%
1/1 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Delusion
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Illusion
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Restlessness
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
50.0%
2/4 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
40.0%
2/5 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Dermatillomania
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Hallucination
|
16.7%
1/6 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Negativism
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
100.0%
1/1 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
50.0%
2/4 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
50.0%
2/4 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
60.0%
3/5 • Number of events 3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
33.3%
1/3 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 2 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
25.0%
1/4 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/3 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/5 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/4 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
20.0%
1/5 • Number of events 1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
0.00%
0/1 • DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place