Trial Outcomes & Findings for A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD (NCT NCT01761292)
NCT ID: NCT01761292
Last Updated: 2023-11-07
Results Overview
The primary endpoint was the change in histology comparing the brachial biceps biopsies before and after ≥12 months of treatment with Givinostat. Muscle biopsies: A first brachial biceps biopsy (baseline) was taken prior to the first dose of study drug. A second brachial biceps biopsy was taken at Visit 10 (12 months) from the opposite arm. The muscle biopsy samples from the biceps muscle were collected by open biopsy. The minimum amount of muscle tissue required was a piece of muscle of at least 0.5 × 0.5 × 0.5 cm.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
After12 months of treatment
Results posted on
2023-11-07
Participant Flow
This is a single arm study and not a parallel group study. Patient enrollment occurred sequentially, until 20 patients were treated (part 1). For the entire design please refer to "detailed study description". Only demographics are reported by 3 Givinostat dose levels, while AEs and outcomes results are reported for the whole Givinostat population.
Participant milestones
| Measure |
Givinostat
Givinostat will be administered as 2 oral doses daily while the child is in fed state.
Givinostat: Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, administered orally under fed conditions at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1 and 25 mg BID and 37.5 mg BID during Part 2. Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID or 37.5 mg BID during Extension 1, and modified as per patient's weight during Extensions 2 and 3.
|
|---|---|
|
Part 1
STARTED
|
20
|
|
Part 1
Patients Receiving Drug in Part 1
|
19
|
|
Part 1
COMPLETED
|
18
|
|
Part 1
NOT COMPLETED
|
2
|
|
Part 2
STARTED
|
19
|
|
Part 2
COMPLETED
|
19
|
|
Part 2
NOT COMPLETED
|
0
|
|
Extension 1
STARTED
|
19
|
|
Extension 1
COMPLETED
|
18
|
|
Extension 1
NOT COMPLETED
|
1
|
|
Extension 2
STARTED
|
18
|
|
Extension 2
COMPLETED
|
18
|
|
Extension 2
NOT COMPLETED
|
0
|
|
Extension 3
STARTED
|
18
|
|
Extension 3
COMPLETED
|
18
|
|
Extension 3
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Givinostat
Givinostat will be administered as 2 oral doses daily while the child is in fed state.
Givinostat: Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, administered orally under fed conditions at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1 and 25 mg BID and 37.5 mg BID during Part 2. Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID or 37.5 mg BID during Extension 1, and modified as per patient's weight during Extensions 2 and 3.
|
|---|---|
|
Part 1
Adverse Event
|
1
|
|
Part 1
not receiving treatment in Part 1
|
1
|
|
Extension 1
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD
Baseline characteristics by cohort
| Measure |
ITF2357 25 mg BID
n=4 Participants
Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID, during Part 1 and 25 mg BID during Part 2 and during Extension 1.
The dosage was modified as per patient's weight during Extensions 2 and 3.
|
ITF2357 50 mg BID
n=8 Participants
Givinostat oral capsules 50 mg, administered orally under fed conditions at the dose of 50 mg BID during Part 1.
The dosage was modified as per patient's weight during Extensions 2 and 3.
|
ITF2357 37.5 mg BID
n=8 Participants
Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 37.5 mg BID during Part 1 and 37.5 mg BID during Part 2 and during Extension 1.
The dosage was modified as per patient's weight during Extensions 2 and 3.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
7.8 years
STANDARD_DEVIATION 0.96 • n=93 Participants
|
8.8 years
STANDARD_DEVIATION 1.16 • n=4 Participants
|
7.9 years
STANDARD_DEVIATION 1.13 • n=27 Participants
|
8.2 years
STANDARD_DEVIATION 1.15 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
20 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: After12 months of treatmentPopulation: Evaluable population:all patients who received givinostat of at least 80% dose in Part 2, had at least 1 baseline and 1 post baseline biopsy and no major protocol violations. 19 Subjects completed Part 2, 1 subject was excluded by this analysis due to biopsy not readable. Results data are reported only for the "overall" Givinostat population.
The primary endpoint was the change in histology comparing the brachial biceps biopsies before and after ≥12 months of treatment with Givinostat. Muscle biopsies: A first brachial biceps biopsy (baseline) was taken prior to the first dose of study drug. A second brachial biceps biopsy was taken at Visit 10 (12 months) from the opposite arm. The muscle biopsy samples from the biceps muscle were collected by open biopsy. The minimum amount of muscle tissue required was a piece of muscle of at least 0.5 × 0.5 × 0.5 cm.
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline to Part 2 in the Value of Muscle Fiber Area (MFA) % Comparing the Histology Biopsies Before and After 12 Months of Treatment With Givinostat.
|
12.76 percentage change
Interval 6.17 to 21.23
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 or entered the Part 2 of the study. For histology parameters patients were analyzed "overall" for Givinostat population. 19 completed part 2 but only 18 subejcts had 2 biopsies readable
This histological parameter was evaluated on the brachial biceps biopsies taken prior to the first dose of study drug and after 12 months of treatment with givinostat.
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline to End of Study in Cross Sectional Area (CSA)
|
865.269 μm2
Standard Deviation 555.3543
|
SECONDARY outcome
Timeframe: After 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 or entered the Part 2 of the study. For histology parameters patients were analyzed "overall" for Givinostat population. 19 Subjects completed Part 2 but only 18 had 2 biopsies readable.
These histological parameters were evaluated on the brachial biceps biopsies taken prior to the first dose of study drug and after 12 months of treatment with givinostat.
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline to End of Study in Fibrosis, Necrosis, Fatty Replacement
Total fibrosis
|
-12.640 percentage of total area
Standard Deviation 4.6493
|
|
Change From Baseline to End of Study in Fibrosis, Necrosis, Fatty Replacement
Perimysial fibrosis
|
-7.585 percentage of total area
Standard Deviation 6.4779
|
|
Change From Baseline to End of Study in Fibrosis, Necrosis, Fatty Replacement
Endomysial fibrosis
|
-5.056 percentage of total area
Standard Deviation 6.2531
|
|
Change From Baseline to End of Study in Fibrosis, Necrosis, Fatty Replacement
Fatty replacement
|
-0.302 percentage of total area
Standard Deviation 0.2756
|
|
Change From Baseline to End of Study in Fibrosis, Necrosis, Fatty Replacement
Necrosis
|
-0.964 percentage of total area
Standard Deviation 0.6260
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 or entered the Part 2 of the study. For histology parameters patients were analyzed "overall" for Givinostat population.19 Subjects completed Part 2 but only 18 had 2 biopsies readable.
This histological parameter was evaluated on the brachial biceps biopsies taken prior to the first dose of study drug and after 12 months of treatment with givinostat. The number of fibers is calculated per microscopic field (20x).
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline to End of Study in Number of Hypercontracted Fibers
|
-1.204 number of fibers
Standard Deviation 0.6621
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Results data are reported only for the "overall" Givinostat population, due to a small sample. 19 subjects completed Part 2 of the study 19 but only 18 performed the 6-Minute Walk Test
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The 6-Minute Walk Test is a useful measure of functional capacity targeted at people with at least moderately severe impairment. The longer the walked distance the better the outcome.
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After 12 Months of Treatment With Givinostat at the Selected Daily Dose Based on the 6-Minute Walk Test
|
-24.6 meters
Standard Deviation 36.11
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Patients were analyzed "overall" due to a small sample size. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population
The NSAA, which is composed by 17 items, was graded, for each item, using the standard scorecard with each assessment rated as 0 - unable to achieve independently, 1 - modified method but achieves goal independent of physical assistance from another, or 2 - normal with no obvious modification of activity. The subscales scores are summed up to compute a total score, ranging from 0 to 34. The higher the total score, the better the outcome. The mean Change From Baseline to EoS in NSAA total score is reported hereunder.
Outcome measures
| Measure |
Overall
n=19 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After 12 Months of Treatment With Givinostat at the Selected Daily Dose Based on the North Star Ambulatory Assessment (NSAA)
|
-2.8 score on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Patients were analyzed overall, due to a small sample size. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population.
The PUL (version 1.2) was used to assess the change in motor performance of the upper limb over time in patients with Becker and Duchenne muscular dystrophy, from when they are still ambulant, until they loose all arm function when non-ambulant. The revised version of the PUL included 22 items. These include one entry item to define the starting functional level, and 21 items subdivided into: * shoulder level (Question B to E; minimum score 0 and maximum score 16) * elbow level (Question F to N; minimum score 0 and maximum score 34) * distal level dimension (Question O to V; minimum score 0 and maximum score 24) The total score is calculated by the sum of all the scores of the three subscales (total score range: 0-74) (scores from Question A "entry item" did not contribute). For all items, the higher the score, the better the outcome.
Outcome measures
| Measure |
Overall
n=19 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After 12 Months of Treatment With Givinostat at the Selected Daily Dose Based on the Performance of Upper Limb (PUL)
|
-0.2 score on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: At 24, 36, and 52 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Patients were analyzed overall, due to a small sample size. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The 6-Minute Walk Test is a useful measure of functional capacity targeted at people with at least moderately severe impairment. The longer the walked distance the better the outcome.
Outcome measures
| Measure |
Overall
n=19 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the 6-Minute Walk Test
Extension 1
|
-80.0 meters
Standard Deviation 110.69
|
|
Change From Baseline in Muscular Function After After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the 6-Minute Walk Test
Extension 2
|
-127.0 meters
Standard Deviation 110.40
|
|
Change From Baseline in Muscular Function After After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the 6-Minute Walk Test
Extension 3
|
-287.8 meters
Standard Deviation 159.47
|
SECONDARY outcome
Timeframe: At 24, 36, and 52 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Patients were analyzed overall due to a small sample size. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population.
The NSAA, which is composed by 17 items, was graded, for each item, using the standard scorecard with each assessment rated as 0 - unable to achieve independently, 1 - modified method but achieves goal independent of physical assistance from another, or 2 - normal with no obvious modification of activity. The subscales scores are summed up to compute a total score, ranging from 0 to 34. The higher the total score, the better the outcome. The mean Change From Baseline to EoS in NSAA total score is reported hereunder.
Outcome measures
| Measure |
Overall
n=18 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the North Star Ambulatory Assessment (NSAA)
Extension 1
|
-5.2 score on a scale
Standard Deviation 5.06
|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the North Star Ambulatory Assessment (NSAA)
Extension 2
|
-7.4 score on a scale
Standard Deviation 5.90
|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the North Star Ambulatory Assessment (NSAA)
Extension 3
|
-15.2 score on a scale
Standard Deviation 7.83
|
SECONDARY outcome
Timeframe: At 24, 36, and 52 monthsPopulation: The ITT population included all children who were enrolled in the Part 1 portion or entered the Part 2 portion of the study. Patients were analyzed overall due to a small sample size. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population.
The PUL (version 1.2) was used to assess the change in motor performance of the upper limb over time in patients with Becker and Duchenne muscular dystrophy, from when they are still ambulant, until they loose all arm function when non-ambulant. The revised version of the PUL included 22 items taking. These include one entry item to define the starting functional level, and 21 items subdivided into: * shoulder level (Question B to E; minimum score 0 and maximum score 16) * elbow level (Question F to N; minimum score 0 and maximum score 34) * distal level dimension (Question O to V; minimum score 0 and maximum score 24) The total score is calculated by the sum of all the scores of the three subscales (total score range: 0-74) (scores from Question A "entry item" did not contribute). For all items, the higher the score, the better the outcome.
Outcome measures
| Measure |
Overall
n=19 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the Performance of Upper Limb (PUL)
Extension 1
|
-0.2 score on a scale
Standard Deviation 2.71
|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the Performance of Upper Limb (PUL)
Extension 2
|
-0.2 score on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Muscular Function After 24 (Extension 1), 36 (Extension 2), and 52 Months (Extension 3) of Treatment With Givinostat at the Selected Daily Dose Based on the Performance of Upper Limb (PUL)
Extension 3
|
-4.4 score on a scale
Standard Deviation 6.09
|
SECONDARY outcome
Timeframe: Part 1, Part 2, and Extensions 1, 2, and 3Population: The safety population included all children who received any investigational product. Although different Givinostat dose levels were administered, results data are reported only for the "overall" Givinostat population. During the extension period the dosage was adjusted by patient weight
Summary of Treatment-emergent Adverse Events (TEAE) Reporting from Baseline to the End of Extension 3 (Month 52). In the analysis were included: Any TEAE, Any treatment-related TEAE, Any mild or moderate or severe TEAE, Any life-threatening or disabling TEAE, Any TEAE resulting in death, any serious adverse event, and Any TEAE resulting in study discontinuation.
Outcome measures
| Measure |
Overall
n=20 Participants
Givinostat was administered as 2 oral doses daily while the child is in fed state.
Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, was administered at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1, and 25 mg BID and 37.5 mg BID during Part 2.
|
|---|---|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
TEAEs
|
20 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any treatment-related TEAE
|
20 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any mild TEAE
|
20 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any moderate TEAE
|
16 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any severe TEAE
|
9 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any life-threatening or disabling TEAE
|
1 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Ant TEAE resulting in death
|
0 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any SAE
|
8 participants
|
|
Number of Children Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Type and Severity of TEAEs
Any TEAE resulting in study discontinuation
|
1 participants
|
Adverse Events
Part 1 - 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - 50 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 1 - 37.5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 - 37.5 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 2 - 25 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Overall (Part 1 + Part 2 + Extensions 1, 2, 3 )
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 - 25 mg
n=4 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 1 - 50 mg
n=12 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 1 - 37.5 mg
n=7 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 2 - 37.5 mg
n=19 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 2.
|
Part 2 - 25 mg
n=12 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 2.
|
Overall (Part 1 + Part 2 + Extensions 1, 2, 3 )
n=20 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1 and 19 patients were included in the safety population of Part 2.
In all Extensions, the Safety Analysis Population was set up to 20 patients (100%), including all patients who received any investigational product.
|
|---|---|---|---|---|---|---|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Eye disorders
Cataracts
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Femural fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Lower limb fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
Other adverse events
| Measure |
Part 1 - 25 mg
n=4 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 1 - 50 mg
n=12 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 1 - 37.5 mg
n=7 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1.
|
Part 2 - 37.5 mg
n=19 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 2.
|
Part 2 - 25 mg
n=12 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 2.
|
Overall (Part 1 + Part 2 + Extensions 1, 2, 3 )
n=20 participants at risk
The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received.
19 patients were included in the safety population of Part 1 and 19 patients were included in the safety population of Part 2.
In all Extensions, the Safety Analysis Population was set up to 20 patients (100%), including all patients who received any investigational product.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Left ventricular dilatation
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Left ventricular disfunction
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Endocrine disorders
Delayed puberty
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Endocrine disorders
Secondary adrenocartical insufficiency
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Eye disorders
Lens discoloration
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Eye disorders
Lenticular opacity
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
28.6%
2/7 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
26.3%
5/19 • Number of events 6 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
55.0%
11/20 • Number of events 19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
41.7%
5/12 • Number of events 8 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
42.9%
3/7 • Number of events 4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
47.4%
9/19 • Number of events 23 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
50.0%
6/12 • Number of events 14 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
75.0%
15/20 • Number of events 66 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
25.0%
3/12 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
40.0%
8/20 • Number of events 11 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.8%
3/19 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
25.0%
3/12 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
45.0%
9/20 • Number of events 20 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
25.0%
5/20 • Number of events 6 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
45.0%
9/20 • Number of events 14 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
16.7%
2/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Infections and infestations
Varicella
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
16.7%
2/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
40.0%
8/20 • Number of events 9 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Legament injury
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Legament sprain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
25.0%
5/20 • Number of events 7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Spinal cord injury sacral
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
68.4%
13/19 • Number of events 18 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
41.7%
5/12 • Number of events 7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
65.0%
13/20 • Number of events 39 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
33.3%
4/12 • Number of events 6 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
20.0%
4/20 • Number of events 7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
21.1%
4/19 • Number of events 5 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
16.7%
2/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
35.0%
7/20 • Number of events 8 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Metabolism and nutrition disorders
Hypertryglyceridaemia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
20.0%
4/20 • Number of events 4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
14.3%
1/7 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 5 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Tendinous contracture
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
16.7%
2/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 3 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
16.7%
2/12 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
20.0%
4/20 • Number of events 6 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
50.0%
10/20 • Number of events 12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
10.0%
2/20 • Number of events 2 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
8.3%
1/12 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
5.0%
1/20 • Number of events 1 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/7 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/19 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
0.00%
0/12 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
|
15.0%
3/20 • Number of events 5 • Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place