Trial Outcomes & Findings for Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity. (NCT NCT02501928)
NCT ID: NCT02501928
Last Updated: 2020-11-30
Results Overview
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Results posted on
2020-11-30
Participant Flow
This (A0221109) was a long term extension (LTE) study only among Japanese participants who participated and completed the precedent study A0221047 (NCT01557244). Per plan, efficacy outcome measures and treatment-emergent adverse events were reported using merged data of studies A0221047 and A0221109.
A0221047 had 2 cohorts. Cohort 1 had an active comparator phase and Cohort 2 had an efficacy phase followed by a safety extension phase for each cohort. Japanese participants from both cohorts, if consented continued in this LTE study and received the same treatment as in A0221047, per investigator judgment on safety and tolerance of participants.
Participant milestones
| Measure |
Fesoterodine 4 Milligram (mg) Tablet
In precedent study A0221047, participants of cohort 1, with body weight greater than (\>) 25 kilogram (kg), received fesoterodine 4 mg prolonged release (PR) tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Oxybutynin Then Fesoterodine 4 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet in safety extension phase once daily for 12 weeks. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 40 weeks in this LTE study.
|
Oxybutynin Then Fesoterodine 8 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet once daily for 1 week and if tolerated well received 8 mg PR tablet once daily for 11 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 40 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
In precedent study A0220147, participants of cohort 2, with body weight less than or equal to (\<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
In precedent study A0221047, participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
0
|
0
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
2
|
0
|
0
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fesoterodine 4 Milligram (mg) Tablet
In precedent study A0221047, participants of cohort 1, with body weight greater than (\>) 25 kilogram (kg), received fesoterodine 4 mg prolonged release (PR) tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Oxybutynin Then Fesoterodine 4 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet in safety extension phase once daily for 12 weeks. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 40 weeks in this LTE study.
|
Oxybutynin Then Fesoterodine 8 mg Tablet
In precedent study A0221047, participants of cohort 1, with body weight \>25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet once daily for 1 week and if tolerated well received 8 mg PR tablet once daily for 11 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 40 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
In precedent study A0220147, participants of cohort 2, with body weight less than or equal to (\<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
In precedent study A0221047, participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal By Parent/Guardian
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Baseline characteristics by cohort
| Measure |
Fesoterodine 8 mg Tablet
n=2 Participants
Japanese participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and for 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Japanese participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Japanese participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Continuous
|
13.50 years
STANDARD_DEVIATION 0.71 • n=5 Participants
|
7.86 years
STANDARD_DEVIATION 1.68 • n=7 Participants
|
7.33 years
STANDARD_DEVIATION 0.58 • n=5 Participants
|
8.67 years
STANDARD_DEVIATION 2.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109
Participants with SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109
Participants with AEs
|
2 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Visual acuity (VA) was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Acuity at Week 12: Study A0221109
Right Eye: Baseline
|
0.27 LogMAR
Standard Deviation 0.376
|
0.04 LogMAR
Standard Deviation 0.137
|
0.28 LogMAR
Standard Deviation 0.334
|
—
|
—
|
—
|
|
Change From Baseline in Visual Acuity at Week 12: Study A0221109
Right Eye: Change at Week 12
|
0.14 LogMAR
Standard Deviation 0.204
|
-0.03 LogMAR
Standard Deviation 0.083
|
0.04 LogMAR
Standard Deviation 0.067
|
—
|
—
|
—
|
|
Change From Baseline in Visual Acuity at Week 12: Study A0221109
Left Eye: Baseline
|
0.45 LogMAR
Standard Deviation 0.350
|
0.04 LogMAR
Standard Deviation 0.183
|
0.63 LogMAR
Standard Deviation 0.663
|
—
|
—
|
—
|
|
Change From Baseline in Visual Acuity at Week 12: Study A0221109
Left Eye: Change at Week 12
|
0.03 LogMAR
Standard Deviation 0.126
|
0.03 LogMAR
Standard Deviation 0.116
|
0.07 LogMAR
Standard Deviation 0.122
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Acuity at Week 28: Study A0221109
Right Eye
|
0.00 LogMAR
Standard Deviation 0.000
|
0.03 LogMAR
Standard Deviation 0.118
|
0.02 LogMAR
Standard Deviation 0.142
|
—
|
—
|
—
|
|
Change From Baseline in Visual Acuity at Week 28: Study A0221109
Left Eye
|
0.31 LogMAR
Standard Deviation 0.681
|
0.05 LogMAR
Standard Deviation 0.057
|
0.16 LogMAR
Standard Deviation 0.208
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Acuity at Final Visit: Study A0221109
Right Eye
|
0.00 LogMAR
Standard Deviation 0.000
|
0.02 LogMAR
Standard Deviation 0.108
|
0.02 LogMAR
Standard Deviation 0.142
|
—
|
—
|
—
|
|
Change From Baseline in Visual Acuity at Final Visit: Study A0221109
Left Eye
|
0.31 LogMAR
Standard Deviation 0.681
|
0.04 LogMAR
Standard Deviation 0.055
|
0.16 LogMAR
Standard Deviation 0.208
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Accommodation at Week 12: Study A0221109
Right Eye: Baseline
|
9.33 centimeter
Standard Deviation 8.014
|
8.62 centimeter
Standard Deviation 10.938
|
5.56 centimeter
Standard Deviation 4.857
|
—
|
—
|
—
|
|
Change From Baseline in Visual Accommodation at Week 12: Study A0221109
Right Eye: Change at Week 12
|
2.50 centimeter
Standard Deviation 2.593
|
5.86 centimeter
Standard Deviation 13.287
|
6.67 centimeter
Standard Deviation 10.990
|
—
|
—
|
—
|
|
Change From Baseline in Visual Accommodation at Week 12: Study A0221109
Left Eye: Baseline
|
14.00 centimeter
Standard Deviation 13.199
|
9.86 centimeter
Standard Deviation 13.685
|
4.83 centimeter
Standard Deviation 6.835
|
—
|
—
|
—
|
|
Change From Baseline in Visual Accommodation at Week 12: Study A0221109
Left Eye: Change at Week 12
|
-1.83 centimeter
Standard Deviation 2.593
|
3.24 centimeter
Standard Deviation 13.662
|
16.17 centimeter
Standard Deviation 23.806
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Accommodation at Week 28: Study A0221109
Right Eye
|
5.17 centimeter
Standard Deviation 7.307
|
0.78 centimeter
Standard Deviation 2.639
|
-0.11 centimeter
Standard Deviation 1.836
|
—
|
—
|
—
|
|
Change From Baseline in Visual Accommodation at Week 28: Study A0221109
Left Eye
|
3.17 centimeter
Standard Deviation 5.421
|
-0.39 centimeter
Standard Deviation 3.803
|
0.50 centimeter
Standard Deviation 0.707
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Visual Accommodation at Final Visit: Study A0221109
Right Eye
|
5.17 centimeter
Standard Deviation 7.307
|
4.38 centimeter
Standard Deviation 9.833
|
-0.11 centimeter
Standard Deviation 1.836
|
—
|
—
|
—
|
|
Change From Baseline in Visual Accommodation at Final Visit: Study A0221109
Left Eye
|
3.17 centimeter
Standard Deviation 5.421
|
2.86 centimeter
Standard Deviation 9.263
|
0.50 centimeter
Standard Deviation 0.707
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Aggressive behavior: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
52.6 units on a scale
Standard Deviation 3.82
|
50.7 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Aggressive behavior: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 3.53
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Anxious/depressed: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
52.1 units on a scale
Standard Deviation 3.34
|
50.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Anxious/depressed: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.7 units on a scale
Standard Deviation 4.11
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Attention problems: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
53.6 units on a scale
Standard Deviation 3.55
|
53.3 units on a scale
Standard Deviation 4.93
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Attention problems: Change at week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.1 units on a scale
Standard Deviation 2.34
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Rule-breaking behavior: Baseline
|
50.5 units on a scale
Standard Deviation 0.71
|
52.4 units on a scale
Standard Deviation 3.60
|
53.3 units on a scale
Standard Deviation 5.77
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Rule-breaking behavior: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.3 units on a scale
Standard Deviation 4.11
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Social problems: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
52.4 units on a scale
Standard Deviation 2.70
|
54.3 units on a scale
Standard Deviation 6.66
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Social problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 3.65
|
0.7 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Somatic complaints: Baseline
|
51.5 units on a scale
Standard Deviation 2.12
|
53.4 units on a scale
Standard Deviation 5.35
|
55.7 units on a scale
Standard Deviation 4.62
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Somatic complaints: Change at Week 12
|
1.5 units on a scale
Standard Deviation 2.12
|
0.9 units on a scale
Standard Deviation 1.46
|
-2.3 units on a scale
Standard Deviation 2.08
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Thought problems: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
50.9 units on a scale
Standard Deviation 1.46
|
53.0 units on a scale
Standard Deviation 4.36
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Thought problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 1.70
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Withdrawn: Baseline
|
50.0 units on a scale
Standard Deviation 0.00
|
53.4 units on a scale
Standard Deviation 4.86
|
52.7 units on a scale
Standard Deviation 4.62
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Withdrawn: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.7 units on a scale
Standard Deviation 4.54
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Externalizing problems: Baseline
|
37.0 units on a scale
Standard Deviation 4.24
|
47.6 units on a scale
Standard Deviation 8.79
|
44.0 units on a scale
Standard Deviation 10.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Externalizing problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.3 units on a scale
Standard Deviation 6.07
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Internalizing problems: Baseline
|
36.0 units on a scale
Standard Deviation 4.24
|
49.0 units on a scale
Standard Deviation 3.79
|
47.7 units on a scale
Standard Deviation 7.51
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Internalizing problems: Change at Week 12
|
3.0 units on a scale
Standard Deviation 4.24
|
0.4 units on a scale
Standard Deviation 5.00
|
-4.0 units on a scale
Standard Deviation 2.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Total problems: Baseline
|
30.5 units on a scale
Standard Deviation 2.12
|
49.1 units on a scale
Standard Deviation 3.67
|
46.7 units on a scale
Standard Deviation 11.59
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109
Total problems: Change at Week 12
|
3.0 units on a scale
Standard Deviation 4.24
|
-1.1 units on a scale
Standard Deviation 2.12
|
0.3 units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Aggressive behavior
|
0.0 units on a scale
Standard Deviation 0.00
|
-2.2 units on a scale
Standard Deviation 3.76
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Anxious/depressed
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.7 units on a scale
Standard Deviation 4.13
|
0.3 units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Attention problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.0 units on a scale
Standard Deviation 2.45
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Rule-breaking behavior
|
-0.5 units on a scale
Standard Deviation 0.71
|
-1.0 units on a scale
Standard Deviation 2.97
|
1.3 units on a scale
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Social problems
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 1.63
|
1.0 units on a scale
Standard Deviation 1.73
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Somatic complaints
|
0.0 units on a scale
Standard Deviation 0.00
|
1.2 units on a scale
Standard Deviation 1.83
|
-2.3 units on a scale
Standard Deviation 2.08
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Thought problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.2 units on a scale
Standard Deviation 0.41
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Withdrawn
|
0.0 units on a scale
Standard Deviation 0.00
|
-2.0 units on a scale
Standard Deviation 7.04
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Externalizing problems
|
-3.0 units on a scale
Standard Deviation 4.24
|
-3.5 units on a scale
Standard Deviation 5.92
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Internalizing problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-2.5 units on a scale
Standard Deviation 6.83
|
-2.7 units on a scale
Standard Deviation 3.06
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109
Total problems
|
-2.5 units on a scale
Standard Deviation 3.54
|
-1.7 units on a scale
Standard Deviation 2.94
|
1.0 units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Aggressive behavior
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.9 units on a scale
Standard Deviation 3.53
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Anxious/depressed
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.6 units on a scale
Standard Deviation 3.78
|
0.3 units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Attention problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.9 units on a scale
Standard Deviation 2.27
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Rule-breaking behavior
|
-0.5 units on a scale
Standard Deviation 0.71
|
-0.9 units on a scale
Standard Deviation 2.73
|
1.3 units on a scale
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Social problems
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 1.50
|
1.0 units on a scale
Standard Deviation 1.73
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Somatic complaints
|
0.0 units on a scale
Standard Deviation 0.00
|
1.0 units on a scale
Standard Deviation 1.73
|
-2.3 units on a scale
Standard Deviation 2.08
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Thought problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.38
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Withdrawn
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.7 units on a scale
Standard Deviation 6.47
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Externalizing problems
|
-3.0 units on a scale
Standard Deviation 4.24
|
-3.0 units on a scale
Standard Deviation 5.57
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Internalizing problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-2.1 units on a scale
Standard Deviation 6.31
|
-2.7 units on a scale
Standard Deviation 3.06
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109
Total problems
|
-2.5 units on a scale
Standard Deviation 3.54
|
-1.4 units on a scale
Standard Deviation 2.76
|
1.0 units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Aggressive behavior: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
3.4 units on a scale
Standard Deviation 3.05
|
2.0 units on a scale
Standard Deviation 2.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Aggressive behavior: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 2.97
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Anxious/depressed: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
1.9 units on a scale
Standard Deviation 1.57
|
1.3 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Anxious/depressed: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 1.60
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Attention problems: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
3.6 units on a scale
Standard Deviation 2.64
|
3.0 units on a scale
Standard Deviation 3.46
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Attention problems: Change at week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.6 units on a scale
Standard Deviation 1.27
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Rule-breaking behavior: Baseline
|
0.5 units on a scale
Standard Deviation 0.71
|
1.3 units on a scale
Standard Deviation 1.50
|
1.3 units on a scale
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Rule-breaking behavior: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 1.21
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Social problems: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
1.6 units on a scale
Standard Deviation 1.27
|
2.3 units on a scale
Standard Deviation 3.21
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Social problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 1.63
|
0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Somatic complaints: Baseline
|
0.5 units on a scale
Standard Deviation 0.71
|
1.0 units on a scale
Standard Deviation 1.53
|
1.7 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Somatic complaints: Change at Week 12
|
0.5 units on a scale
Standard Deviation 0.71
|
0.3 units on a scale
Standard Deviation 0.49
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Thought problems: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
0.6 units on a scale
Standard Deviation 0.79
|
1.3 units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Thought problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.69
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Withdrawn: Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
0.9 units on a scale
Standard Deviation 1.21
|
0.7 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Withdrawn: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.4 units on a scale
Standard Deviation 1.13
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Externalizing problems: Baseline
|
0.5 units on a scale
Standard Deviation 0.71
|
4.7 units on a scale
Standard Deviation 4.27
|
3.3 units on a scale
Standard Deviation 4.16
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Externalizing problems: Change at Week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.3 units on a scale
Standard Deviation 3.59
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Internalizing problems: Baseline
|
0.5 units on a scale
Standard Deviation 0.71
|
3.7 units on a scale
Standard Deviation 1.38
|
3.7 units on a scale
Standard Deviation 2.31
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Internalizing problems: Change at Week 12
|
0.5 units on a scale
Standard Deviation 0.71
|
0.1 units on a scale
Standard Deviation 2.19
|
-1.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Total problems: Baseline
|
1.5 units on a scale
Standard Deviation 0.71
|
19.1 units on a scale
Standard Deviation 5.79
|
18.0 units on a scale
Standard Deviation 17.78
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109
Total problems: Change at Week 12
|
1.0 units on a scale
Standard Deviation 1.41
|
-1.3 units on a scale
Standard Deviation 4.07
|
-0.3 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Aggressive behavior
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.8 units on a scale
Standard Deviation 3.06
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Anxious/depressed
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.3 units on a scale
Standard Deviation 1.37
|
0.0 units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Attention problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.5 units on a scale
Standard Deviation 1.22
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Rule-breaking behavior
|
-0.5 units on a scale
Standard Deviation 0.71
|
-0.2 units on a scale
Standard Deviation 0.98
|
0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Social problems
|
0.0 units on a scale
Standard Deviation 0.00
|
0.2 units on a scale
Standard Deviation 0.98
|
0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Somatic complaints
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 0.52
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Thought problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.2 units on a scale
Standard Deviation 0.41
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Withdrawn
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.5 units on a scale
Standard Deviation 1.76
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Externalizing problems
|
-0.5 units on a scale
Standard Deviation 0.71
|
-2.0 units on a scale
Standard Deviation 3.58
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Internalizing problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.5 units on a scale
Standard Deviation 2.88
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109
Total problems
|
-0.5 units on a scale
Standard Deviation 0.71
|
-2.7 units on a scale
Standard Deviation 4.63
|
0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Aggressive behavior
|
0.0 units on a scale
Standard Deviation 0.00
|
-1.6 units on a scale
Standard Deviation 2.88
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Anxious/depressed
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.3 units on a scale
Standard Deviation 1.25
|
0.0 units on a scale
Standard Deviation 1.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Attention problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.4 units on a scale
Standard Deviation 1.13
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Rule-breaking behavior
|
-0.5 units on a scale
Standard Deviation 0.71
|
-0.1 units on a scale
Standard Deviation 0.90
|
0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Social problems
|
0.0 units on a scale
Standard Deviation 0.00
|
0.1 units on a scale
Standard Deviation 0.90
|
0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Somatic complaints
|
0.0 units on a scale
Standard Deviation 0.00
|
0.3 units on a scale
Standard Deviation 0.49
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Thought problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.38
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Withdrawn
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.4 units on a scale
Standard Deviation 1.62
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Externalizing problems
|
-0.5 units on a scale
Standard Deviation 0.71
|
-1.7 units on a scale
Standard Deviation 3.35
|
0.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Internalizing problems
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.4 units on a scale
Standard Deviation 2.64
|
-0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109
Total problems
|
-0.5 units on a scale
Standard Deviation 0.71
|
-2.3 units on a scale
Standard Deviation 4.35
|
0.7 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109
Dominant hand: Baseline
|
—
|
43.0 seconds
Standard Deviation 23.44
|
39.3 seconds
Standard Deviation 15.18
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109
Dominant hand: Change at Week 12
|
—
|
0.8 seconds
Standard Deviation 6.72
|
-0.3 seconds
Standard Deviation 15.28
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109
Non-dominant hand: Baseline
|
—
|
33.4 seconds
Standard Deviation 10.74
|
52.0 seconds
Standard Deviation 19.67
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109
Non-dominant hand: Change at Week 12
|
—
|
8.2 seconds
Standard Deviation 19.93
|
-1.3 seconds
Standard Deviation 9.45
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=4 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109
Dominant hand
|
—
|
4.5 seconds
Standard Deviation 2.38
|
3.7 seconds
Standard Deviation 4.04
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109
Non-dominant hand
|
—
|
6.3 seconds
Standard Deviation 7.37
|
-7.7 seconds
Standard Deviation 10.26
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Dominant hand
|
—
|
0.8 seconds
Standard Deviation 8.53
|
3.7 seconds
Standard Deviation 4.04
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Non-dominant hand
|
—
|
4.4 seconds
Standard Deviation 7.60
|
-7.7 seconds
Standard Deviation 10.26
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109
Dominant hand: Baseline
|
59.5 seconds
Standard Deviation 6.36
|
107.5 seconds
Standard Deviation 75.66
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109
Dominant hand: Change at Week 12
|
0.0 seconds
Standard Deviation 2.83
|
-11.5 seconds
Standard Deviation 13.44
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109
Non-dominant hand: Baseline
|
60.5 seconds
Standard Deviation 6.36
|
145.5 seconds
Standard Deviation 132.23
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109
Non-dominant hand: Change at Week 12
|
-0.5 seconds
Standard Deviation 4.95
|
-2.0 seconds
Standard Deviation 9.90
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109
Dominant hand
|
2.0 seconds
Standard Deviation 7.07
|
-14.0 seconds
Standard Deviation 24.04
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109
Non-dominant hand
|
-1.0 seconds
Standard Deviation 2.83
|
-35.0 seconds
Standard Deviation 48.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Dominant hand
|
2.08 seconds
Standard Deviation 7.07
|
-14.0 seconds
Standard Deviation 24.04
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109
Non-dominant hand
|
-1.0 seconds
Standard Deviation 2.83
|
-35.0 seconds
Standard Deviation 48.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Dominant hand: Baseline
|
—
|
0.2 pegs
Standard Deviation 0.45
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Dominant hand: Change at Week 12
|
—
|
0.2 pegs
Standard Deviation 0.45
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Non-dominant hand: Baseline
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Non-dominant hand: Change at Week 12
|
—
|
0.6 pegs
Standard Deviation 1.34
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=4 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Dominant hand
|
—
|
0.3 pegs
Standard Deviation 0.96
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Non-dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of Study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Dominant hand
|
—
|
0.2 pegs
Standard Deviation 0.84
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Non-dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Dominant hand: Baseline
|
0.0 pegs
Standard Deviation 0.00
|
0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Dominant hand: Change at Week 12
|
0.0 pegs
Standard Deviation 0.00
|
-0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Non-dominant hand: Baseline
|
0.0 pegs
Standard Deviation 0.00
|
0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109
Non-dominant hand: Change at Week 12
|
0.0 pegs
Standard Deviation 0.00
|
-0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109
Non-dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
-0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109
Non-dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
-0.5 pegs
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Dominant hand: Baseline
|
—
|
10.0 pegs
Standard Deviation 0.00
|
10.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Dominant hand: Change at Week 12
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand: Baseline
|
—
|
10.0 pegs
Standard Deviation 0.00
|
10.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand: Change at Week 12
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=4 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arm "Fesoterodine 8 mg Tablet" was below age of 9 years.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=5 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand
|
—
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Dominant hand: Baseline
|
25.0 pegs
Standard Deviation 0.00
|
25.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Dominant hand: Change at Week 12
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand: Baseline
|
25.0 pegs
Standard Deviation 0.00
|
25.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand: Change at Week 12
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in the reporting arm "Fesoterodine 4 mg Capsule" was of age 9 years and above.
The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109
Non-dominant hand
|
0.0 pegs
Standard Deviation 0.00
|
0.0 pegs
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109
Systolic blood pressure
|
6.0 millimeter of mercury
Standard Deviation 4.24
|
2.1 millimeter of mercury
Standard Deviation 9.65
|
5.0 millimeter of mercury
Standard Deviation 14.11
|
—
|
—
|
—
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109
Diastolic blood pressure
|
10.5 millimeter of mercury
Standard Deviation 4.95
|
-0.9 millimeter of mercury
Standard Deviation 8.90
|
6.3 millimeter of mercury
Standard Deviation 15.31
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109
Systolic blood pressure
|
8.5 millimeter of mercury
Standard Deviation 16.26
|
5.7 millimeter of mercury
Standard Deviation 11.18
|
9.7 millimeter of mercury
Standard Deviation 2.52
|
—
|
—
|
—
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109
Diastolic blood pressure
|
12.0 millimeter of mercury
Standard Deviation 4.24
|
5.3 millimeter of mercury
Standard Deviation 9.03
|
10.7 millimeter of mercury
Standard Deviation 2.52
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109
Systolic blood pressure
|
8.5 millimeter of mercury
Standard Deviation 16.26
|
5.1 millimeter of mercury
Standard Deviation 10.30
|
9.7 millimeter of mercury
Standard Deviation 2.52
|
—
|
—
|
—
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109
Diastolic blood pressure
|
12.0 millimeter of mercury
Standard Deviation 4.24
|
4.6 millimeter of mercury
Standard Deviation 8.48
|
10.7 millimeter of mercury
Standard Deviation 2.52
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109
|
0.0 beats per minute
Standard Deviation 18.38
|
2.4 beats per minute
Standard Deviation 12.53
|
-8.0 beats per minute
Standard Deviation 2.00
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.
Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=6 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109
|
-3.5 beats per minute
Standard Deviation 6.36
|
-2.7 beats per minute
Standard Deviation 8.82
|
-3.7 beats per minute
Standard Deviation 9.61
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109
|
-3.5 beats per minute
Standard Deviation 6.36
|
-1.4 beats per minute
Standard Deviation 8.70
|
-3.7 beats per minute
Standard Deviation 9.61
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109.
UTI data were summarized for each cohort, each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: A0221109: Baseline to 28 weeksPopulation: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in Study A0221109.
Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN); platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN); leukocytes \<0.6\*LLN\>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN \>1.2\*UL; basophils, eosinophils, monocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct bilirubin \>1.5\*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein, albumin \<0.8\*LLN \>1.2\*ULN; blood urea nitrogen, creatinine \>1.3\*ULN; urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN; potassium, chloride, bicarbonate \<0.9\*LLN\>1.1\*ULN; glucose \<0.6\*LLN\>1.5\*ULN; creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, glucose, ketones, protein, hemoglobin, nitrite, leukocyte esterase \>=1; erythrocytes, leukocytes \>=20; epithelial cells \>=6, bacteria \>20, hyaline casts \>1. Data for this outcome was planned to be analysed for each treatment group of study A0221109 only.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=7 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=3 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
|
2 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 12Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Post-void residual volume was assessed by an ultrasound. PVR volume was assessed only in participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: A0221109: Baseline, Week 28Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Safety analysis set included all participants who were enrolled and received at least one dose of study medication in study A0221109. All participants performed clean intermittent catheterization, hence were not eligible for post-void residual volume assessment.
Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: Full analysis set (FAS) included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Maximum cystometric bladder capacity was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O). Maximum cystometric bladder capacity was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
181.0 milliliter
Standard Deviation 28.28
|
135.5 milliliter
Standard Deviation 45.21
|
181.0 milliliter
Standard Deviation 28.28
|
149.7 milliliter
Standard Deviation 38.49
|
102.3 milliliter
Standard Deviation 48.95
|
143.1 milliliter
Standard Deviation 45.37
|
|
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
153.0 milliliter
Standard Deviation 56.57
|
42.9 milliliter
Standard Deviation 31.01
|
153.0 milliliter
Standard Deviation 56.57
|
37.6 milliliter
Standard Deviation 28.83
|
55.3 milliliter
Standard Deviation 38.76
|
61.3 milliliter
Standard Deviation 53.98
|
|
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
121.5 milliliter
Standard Deviation 30.41
|
37.9 milliliter
Standard Deviation 53.99
|
121.5 milliliter
Standard Deviation 30.41
|
32.8 milliliter
Standard Deviation 52.42
|
48.0 milliliter
Standard Deviation 67.55
|
53.1 milliliter
Standard Deviation 59.74
|
|
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
121.5 milliliter
Standard Deviation 30.41
|
37.9 milliliter
Standard Deviation 53.99
|
121.5 milliliter
Standard Deviation 30.41
|
32.8 milliliter
Standard Deviation 52.42
|
48.0 milliliter
Standard Deviation 67.55
|
53.1 milliliter
Standard Deviation 59.74
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Detrusor pressure (cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing. Detrusor pressure was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
29.0 cm H2O
Standard Deviation 8.49
|
40.2 cm H2O
Standard Deviation 31.34
|
29.0 cm H2O
Standard Deviation 8.49
|
32.4 cm H2O
Standard Deviation 11.57
|
58.3 cm H2O
Standard Deviation 57.55
|
38.3 cm H2O
Standard Deviation 28.79
|
|
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
-5.5 cm H2O
Standard Deviation 0.71
|
-13.7 cm H2O
Standard Deviation 24.90
|
-5.5 cm H2O
Standard Deviation 0.71
|
-6.0 cm H2O
Standard Deviation 7.85
|
-31.7 cm H2O
Standard Deviation 43.73
|
-12.3 cm H2O
Standard Deviation 22.74
|
|
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
-7.0 cm H2O
Standard Deviation 0.00
|
-4.3 cm H2O
Standard Deviation 23.93
|
-7.0 cm H2O
Standard Deviation 0.00
|
-2.8 cm H2O
Standard Deviation 2.86
|
-7.3 cm H2O
Standard Deviation 47.44
|
-4.8 cm H2O
Standard Deviation 21.43
|
|
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
-7.0 cm H2O
Standard Deviation 0.00
|
-4.3 cm H2O
Standard Deviation 23.93
|
-7.0 cm H2O
Standard Deviation 0.00
|
-2.8 cm H2O
Standard Deviation 2.86
|
-7.3 cm H2O
Standard Deviation 47.44
|
-4.8 cm H2O
Standard Deviation 21.43
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109.
Participants with presence of IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
1 Participants
|
10 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Week 12
|
0 Participants
|
7 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Week 28
|
0 Participants
|
8 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Final Visit
|
0 Participants
|
8 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit. Overall number of participants analyzed=participants evaluable for this outcome measure. Number Analyzed=participants evaluable for this outcome measure for specified rows.
Bladder volume at first IDC was measured using urodynamic testing. Bladder volume at first IDC was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=1 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=11 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
175.0 milliliter
|
48.8 milliliter
Standard Deviation 31.65
|
175.0 milliliter
|
48.1 milliliter
Standard Deviation 36.57
|
50.3 milliliter
Standard Deviation 22.14
|
60.3 milliliter
Standard Deviation 48.47
|
|
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
—
|
95.0 milliliter
Standard Deviation 53.88
|
—
|
113.8 milliliter
Standard Deviation 68.55
|
70.0 milliliter
Standard Deviation 4.58
|
95.0 milliliter
Standard Deviation 53.88
|
|
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
—
|
50.4 milliliter
Standard Deviation 36.38
|
—
|
38.6 milliliter
Standard Deviation 24.46
|
70.0 milliliter
Standard Deviation 50.11
|
50.4 milliliter
Standard Deviation 36.38
|
|
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
—
|
50.4 milliliter
Standard Deviation 36.38
|
—
|
38.6 milliliter
Standard Deviation 24.46
|
70.0 milliliter
Standard Deviation 50.11
|
50.4 milliliter
Standard Deviation 36.38
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated). Bladder Compliance was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
7.00 milliliter per cm H2O
Standard Deviation 2.828
|
6.97 milliliter per cm H2O
Standard Deviation 5.124
|
7.00 milliliter per cm H2O
Standard Deviation 2.828
|
8.16 milliliter per cm H2O
Standard Deviation 5.668
|
4.20 milliliter per cm H2O
Standard Deviation 2.307
|
6.98 milliliter per cm H2O
Standard Deviation 4.712
|
|
Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
9.00 milliliter per cm H2O
Standard Deviation 7.071
|
20.06 milliliter per cm H2O
Standard Deviation 46.151
|
9.00 milliliter per cm H2O
Standard Deviation 7.071
|
23.34 milliliter per cm H2O
Standard Deviation 55.493
|
12.40 milliliter per cm H2O
Standard Deviation 14.855
|
18.22 milliliter per cm H2O
Standard Deviation 42.021
|
|
Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
8.65 milliliter per cm H2O
Standard Deviation 6.152
|
13.22 milliliter per cm H2O
Standard Deviation 16.721
|
8.65 milliliter per cm H2O
Standard Deviation 6.152
|
13.18 milliliter per cm H2O
Standard Deviation 18.628
|
13.30 milliliter per cm H2O
Standard Deviation 15.836
|
12.39 milliliter per cm H2O
Standard Deviation 15.194
|
|
Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
8.65 milliliter per cm H2O
Standard Deviation 6.152
|
13.22 milliliter per cm H2O
Standard Deviation 16.721
|
8.65 milliliter per cm H2O
Standard Deviation 6.152
|
13.18 milliliter per cm H2O
Standard Deviation 18.628
|
13.30 milliliter per cm H2O
Standard Deviation 15.836
|
12.39 milliliter per cm H2O
Standard Deviation 15.194
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arms "Cohort 1", "Fesoterodine 8 mg Tablet" and "Fesoterodine 4 mg Capsule" had \>0 micturitions at baseline.
The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 micturitions at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=4 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=4 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=4 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
—
|
4.58 micturitions per 24 hours
Standard Deviation 4.541
|
—
|
4.58 micturitions per 24 hours
Standard Deviation 4.541
|
—
|
4.58 micturitions per 24 hours
Standard Deviation 4.541
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
—
|
-1.50 micturitions per 24 hours
Standard Deviation 1.036
|
—
|
-1.50 micturitions per 24 hours
Standard Deviation 1.036
|
—
|
-1.50 micturitions per 24 hours
Standard Deviation 1.036
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
—
|
-1.08 micturitions per 24 hours
Standard Deviation 0.631
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
5.33 catheterizations per 24 hours
Standard Deviation 0.943
|
4.47 catheterizations per 24 hours
Standard Deviation 1.390
|
5.33 catheterizations per 24 hours
Standard Deviation 0.943
|
4.24 catheterizations per 24 hours
Standard Deviation 1.641
|
5.00 catheterizations per 24 hours
Standard Deviation 0.000
|
4.61 catheterizations per 24 hours
Standard Deviation 1.332
|
|
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
0.00 catheterizations per 24 hours
Standard Deviation 0.471
|
0.05 catheterizations per 24 hours
Standard Deviation 0.357
|
0.00 catheterizations per 24 hours
Standard Deviation 0.471
|
0.03 catheterizations per 24 hours
Standard Deviation 0.420
|
0.11 catheterizations per 24 hours
Standard Deviation 0.192
|
0.04 catheterizations per 24 hours
Standard Deviation 0.353
|
|
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
0.33 catheterizations per 24 hours
Standard Deviation 0.000
|
-0.09 catheterizations per 24 hours
Standard Deviation 0.278
|
0.33 catheterizations per 24 hours
Standard Deviation 0.000
|
-0.19 catheterizations per 24 hours
Standard Deviation 0.267
|
0.11 catheterizations per 24 hours
Standard Deviation 0.192
|
-0.02 catheterizations per 24 hours
Standard Deviation 0.302
|
|
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
0.33 catheterizations per 24 hours
Standard Deviation 0.000
|
-0.12 catheterizations per 24 hours
Standard Deviation 0.273
|
0.33 catheterizations per 24 hours
Standard Deviation 0.000
|
-0.21 catheterizations per 24 hours
Standard Deviation 0.249
|
0.11 catheterizations per 24 hours
Standard Deviation 0.192
|
-0.04 catheterizations per 24 hours
Standard Deviation 0.303
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The mean number of micturitions and catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour (hr) period. This outcome measure was only calculated for participants with \>0 micturitions or catheterizations at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
0.33 micturitions or catheterizations/24 hr
Standard Deviation 0.000
|
-0.57 micturitions or catheterizations/24 hr
Standard Deviation 0.741
|
0.33 micturitions or catheterizations/24 hr
Standard Deviation 0.000
|
-0.92 micturitions or catheterizations/24 hr
Standard Deviation 0.665
|
0.11 micturitions or catheterizations/24 hr
Standard Deviation 0.192
|
-0.41 micturitions or catheterizations/24 hr
Standard Deviation 0.758
|
|
Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
0.33 micturitions or catheterizations/24 hr
Standard Deviation 0.000
|
-0.55 micturitions or catheterizations/24 hr
Standard Deviation 0.703
|
0.33 micturitions or catheterizations/24 hr
Standard Deviation 0.000
|
-0.83 micturitions or catheterizations/24 hr
Standard Deviation 0.645
|
0.11 micturitions or catheterizations/24 hr
Standard Deviation 0.192
|
-0.40 micturitions or catheterizations/24 hr
Standard Deviation 0.723
|
|
Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
5.33 micturitions or catheterizations/24 hr
Standard Deviation 0.943
|
6.30 micturitions or catheterizations/24 hr
Standard Deviation 2.808
|
5.33 micturitions or catheterizations/24 hr
Standard Deviation 0.943
|
6.86 micturitions or catheterizations/24 hr
Standard Deviation 3.259
|
5.00 micturitions or catheterizations/24 hr
Standard Deviation 0.000
|
6.14 micturitions or catheterizations/24 hr
Standard Deviation 2.584
|
|
Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
0.00 micturitions or catheterizations/24 hr
Standard Deviation 0.471
|
-0.55 micturitions or catheterizations/24 hr
Standard Deviation 1.131
|
0.00 micturitions or catheterizations/24 hr
Standard Deviation 0.471
|
-0.83 micturitions or catheterizations/24 hr
Standard Deviation 1.264
|
0.11 micturitions or catheterizations/24 hr
Standard Deviation 0.192
|
-0.46 micturitions or catheterizations/24 hr
Standard Deviation 1.055
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 incontinence episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
1.17 incontinence episodes per 24 hours
Standard Deviation 0.236
|
3.60 incontinence episodes per 24 hours
Standard Deviation 2.298
|
1.17 incontinence episodes per 24 hours
Standard Deviation 0.236
|
3.48 incontinence episodes per 24 hours
Standard Deviation 2.768
|
3.89 incontinence episodes per 24 hours
Standard Deviation 0.770
|
3.19 incontinence episodes per 24 hours
Standard Deviation 2.285
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
0.50 incontinence episodes per 24 hours
Standard Deviation 0.236
|
-0.18 incontinence episodes per 24 hours
Standard Deviation 1.726
|
0.50 incontinence episodes per 24 hours
Standard Deviation 0.236
|
-0.26 incontinence episodes per 24 hours
Standard Deviation 2.074
|
0.00 incontinence episodes per 24 hours
Standard Deviation 0.667
|
-0.07 incontinence episodes per 24 hours
Standard Deviation 1.586
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
1.83 incontinence episodes per 24 hours
Standard Deviation 0.707
|
-0.31 incontinence episodes per 24 hours
Standard Deviation 1.501
|
1.83 incontinence episodes per 24 hours
Standard Deviation 0.707
|
-0.42 incontinence episodes per 24 hours
Standard Deviation 1.577
|
-0.11 incontinence episodes per 24 hours
Standard Deviation 1.644
|
0.08 incontinence episodes per 24 hours
Standard Deviation 1.615
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
1.83 incontinence episodes per 24 hours
Standard Deviation 0.707
|
0.08 incontinence episodes per 24 hours
Standard Deviation 1.894
|
1.83 incontinence episodes per 24 hours
Standard Deviation 0.707
|
0.17 incontinence episodes per 24 hours
Standard Deviation 2.110
|
-0.11 incontinence episodes per 24 hours
Standard Deviation 1.644
|
0.38 incontinence episodes per 24 hours
Standard Deviation 1.856
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No sensate participants for reporting arms "Cohort 1" and "Fesoterodine 8 mg Tablet" had \>0 urgency episodes at baseline.
The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed, even if it was not a full 24 hour period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for sensate participants with \>0 urgency episodes at Baseline. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=3 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=2 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=1 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=3 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
—
|
0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
—
|
0.75 urgency episodes per 24 hours
Standard Deviation 0.354
|
0.33 urgency episodes per 24 hours
|
0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
—
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
—
|
-0.75 urgency episodes per 24 hours
Standard Deviation 0.354
|
-0.33 urgency episodes per 24 hours
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
—
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
—
|
-0.75 urgency episodes per 24 hours
Standard Deviation 0.354
|
-0.33 urgency episodes per 24 hours
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
—
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
—
|
-0.75 urgency episodes per 24 hours
Standard Deviation 0.354
|
-0.33 urgency episodes per 24 hours
|
-0.61 urgency episodes per 24 hours
Standard Deviation 0.347
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS was analyzed. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. No participant in reporting arms "Cohort 1", "Fesoterodine 8 mg Tablet" and "Fesoterodine 4 mg Capsule" had the records of volume voided per micturition.
The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume \>0. This outcome measure included only participants who actually had the records of volume voided per micturition. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=2 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=2 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=2 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
—
|
73.42 milliliter per micturition
Standard Deviation 42.309
|
—
|
73.42 milliliter per micturition
Standard Deviation 42.309
|
—
|
73.42 milliliter per micturition
Standard Deviation 42.309
|
|
Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
—
|
15.77 milliliter per micturition
Standard Deviation 6.924
|
—
|
15.77 milliliter per micturition
Standard Deviation 6.924
|
—
|
15.77 milliliter per micturition
Standard Deviation 6.924
|
|
Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
|
Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
—
|
4.75 milliliter per micturition
Standard Deviation 14.496
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume \>0. This outcome measure included only participants who actually had the records of volume voided per catherization. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
198.75 milliliter per catheterization
Standard Deviation 44.194
|
58.31 milliliter per catheterization
Standard Deviation 40.187
|
198.75 milliliter per catheterization
Standard Deviation 44.194
|
48.76 milliliter per catheterization
Standard Deviation 39.230
|
80.58 milliliter per catheterization
Standard Deviation 39.841
|
81.72 milliliter per catheterization
Standard Deviation 66.988
|
|
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
-0.92 milliliter per catheterization
Standard Deviation 21.095
|
20.66 milliliter per catheterization
Standard Deviation 21.024
|
-0.92 milliliter per catheterization
Standard Deviation 21.095
|
17.90 milliliter per catheterization
Standard Deviation 17.038
|
27.08 milliliter per catheterization
Standard Deviation 32.086
|
17.06 milliliter per catheterization
Standard Deviation 21.739
|
|
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
-29.42 milliliter per catheterization
Standard Deviation 12.139
|
11.58 milliliter per catheterization
Standard Deviation 27.064
|
-29.42 milliliter per catheterization
Standard Deviation 12.139
|
8.72 milliliter per catheterization
Standard Deviation 33.245
|
17.28 milliliter per catheterization
Standard Deviation 9.659
|
4.12 milliliter per catheterization
Standard Deviation 29.591
|
|
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
-29.42 milliliter per catheterization
Standard Deviation 12.139
|
11.58 milliliter per catheterization
Standard Deviation 27.064
|
-29.42 milliliter per catheterization
Standard Deviation 12.139
|
8.72 milliliter per catheterization
Standard Deviation 33.245
|
17.28 milliliter per catheterization
Standard Deviation 9.659
|
4.12 milliliter per catheterization
Standard Deviation 29.591
|
SECONDARY outcome
Timeframe: Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)Population: FAS included all participants who were enrolled and received at least one dose of study medication and had at least 1 observation in efficacy endpoint data after baseline visit in study A0221109. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.
The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume \>0. Data was summarized for each cohort, each treatment group and total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 Participants
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 Participants
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 Participants
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 Participants
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Baseline
|
198.75 mL per micturition or catheterization
Standard Deviation 44.194
|
65.68 mL per micturition or catheterization
Standard Deviation 34.769
|
198.75 mL per micturition or catheterization
Standard Deviation 44.194
|
59.29 mL per micturition or catheterization
Standard Deviation 33.550
|
80.58 mL per micturition or catheterization
Standard Deviation 39.841
|
87.86 mL per micturition or catheterization
Standard Deviation 62.045
|
|
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 12
|
-0.92 mL per micturition or catheterization
Standard Deviation 21.095
|
17.88 mL per micturition or catheterization
Standard Deviation 17.597
|
-0.92 mL per micturition or catheterization
Standard Deviation 21.095
|
13.94 mL per micturition or catheterization
Standard Deviation 7.801
|
27.08 mL per micturition or catheterization
Standard Deviation 32.086
|
14.75 mL per micturition or catheterization
Standard Deviation 18.638
|
|
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Week 28
|
-29.42 mL per micturition or catheterization
Standard Deviation 12.139
|
12.34 mL per micturition or catheterization
Standard Deviation 26.812
|
-29.42 mL per micturition or catheterization
Standard Deviation 12.139
|
9.86 mL per micturition or catheterization
Standard Deviation 33.029
|
17.28 mL per micturition or catheterization
Standard Deviation 9.659
|
4.75 mL per micturition or catheterization
Standard Deviation 29.583
|
|
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109
Change at Final Visit
|
-29.42 mL per micturition or catheterization
Standard Deviation 12.139
|
12.34 mL per micturition or catheterization
Standard Deviation 26.812
|
-29.42 mL per micturition or catheterization
Standard Deviation 12.139
|
9.86 mL per micturition or catheterization
Standard Deviation 33.029
|
17.28 mL per micturition or catheterization
Standard Deviation 9.659
|
4.75 mL per micturition or catheterization
Standard Deviation 29.583
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Fesoterodine 8 mg Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fesoterodine 2 mg Capsule
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Fesoterodine 4 mg Capsule
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Total of Treatment Groups
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=2 participants at risk
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 participants at risk
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 participants at risk
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 participants at risk
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 participants at risk
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 participants at risk
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
Other adverse events
| Measure |
Cohort 1
n=2 participants at risk
Participants of cohort 1 with body weight \>25 kg, who received fesoterodine 4 mg or 8 mg PR tablet orally once daily for 24 weeks (active comparator and safety extension phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Cohort 2
n=10 participants at risk
Participants of cohort 2 with body weight \<=25 kg, who received either fesoterodine 2 mg or 4 mg capsule orally once daily for 24 weeks (efficacy and safety phase) in precedent study A0221047 and then continued the same dose and dosage form of fesoterodine for 28 weeks in this LTE study.
|
Fesoterodine 8 mg Tablet
n=2 participants at risk
Participants of cohort 1, with body weight \>25 kg, who received fesoterodine 4 mg PR tablet for 1 week and if tolerated well then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 2 mg Capsule
n=7 participants at risk
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Fesoterodine 4 mg Capsule
n=3 participants at risk
Participants of cohort 2, with body weight \<=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study.
|
Total of Treatment Groups
n=12 participants at risk
Total participants who received fesoterodine 8 mg PR tablet, fesoterodine 2 mg and 4 mg BIC capsules in precedent study A0221047 and continued to receive the same treatment respectively, in this LTE study.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Astigmatism
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Eye disorders
Myopia
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
66.7%
2/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Eye disorders
Strabismus
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Eye disorders
Visual acuity reduced
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Gastrointestinal disorders
Anal fissure
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
25.0%
3/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
40.0%
4/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
42.9%
3/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
4/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Bronchitis
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Impetigo
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
28.6%
2/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
60.0%
6/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
57.1%
4/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
66.7%
2/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
58.3%
7/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Injury, poisoning and procedural complications
Chillblains
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Investigations
Urodynamics measurement abnormal
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Product Issues
Device malfunction
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Renal and urinary disorders
Renal failure
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
50.0%
1/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
20.0%
2/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
16.7%
2/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
33.3%
1/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
10.0%
1/10 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/2 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
14.3%
1/7 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
0.00%
0/3 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
8.3%
1/12 • Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated. AEs were summarized for each cohort (Cohort 1 and Cohort 2), each treatment group and the total of treatment groups , using the merged data of studies A0221047 and A0221109 as planned.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER