Trial Outcomes & Findings for A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease (NCT NCT01485172)
NCT ID: NCT01485172
Last Updated: 2018-06-20
Results Overview
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
186 participants
Primary outcome timeframe
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Results posted on
2018-06-20
Participant Flow
Eligible participants (par.) were diagnosed with early stage Parkinson's disease (according to modified Hoehn and Yahr criteria Stages I-III) and randomized at Screening into one of six treatment arms to receive placebo or ropinirole Prolonged Release (PR) tablets.
After Screening, par. underwent a 13 Week Up-Titration Period until reaching their target dose then continued on their target dose during a 4 Week Maintenance Period up to Week 17. All par. underwent a 1 Week Down-Titration Period and then a Follow-Up Visit 1-2 Weeks after receiving the last dose of treatment.
Participant milestones
| Measure |
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
13
|
41
|
40
|
39
|
13
|
|
Overall Study
COMPLETED
|
33
|
12
|
34
|
32
|
34
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
7
|
8
|
5
|
4
|
Reasons for withdrawal
| Measure |
Treatment Group A: Placebo
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
4
|
5
|
1
|
0
|
|
Overall Study
Protocol defined stopping criteria
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Treatment Group A: Placebo
n=40 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=41 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=40 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=39 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 11.12 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
60.3 Years
STANDARD_DEVIATION 11.72 • n=4 Participants
|
61.7 Years
STANDARD_DEVIATION 10.78 • n=21 Participants
|
62.5 Years
STANDARD_DEVIATION 12.88 • n=8 Participants
|
61.6 Years
STANDARD_DEVIATION 10.85 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
91 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian
|
36 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
170 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).
Outcome measures
| Measure |
Treatment Group A: Placebo
n=33 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score
|
-1.91 Score on a scale
Interval -4.15 to 0.34
|
-1.58 Score on a scale
Interval -5.02 to 1.86
|
-2.76 Score on a scale
Interval -5.04 to -0.49
|
-4.31 Score on a scale
Interval -6.48 to -2.15
|
-4.07 Score on a scale
Interval -6.32 to -1.82
|
-2.83 Score on a scale
Interval -6.61 to 0.95
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=35 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=35 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score
|
9 Participants
|
6 Participants
|
14 Participants
|
16 Participants
|
19 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=35 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=35 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score
|
5 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=35 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=35 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined
|
6 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The responder rate is defined as the percentage of participants with a greater than or equal to (\>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=35 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=35 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score
|
18 Percentage of Participants
|
31 Percentage of Participants
|
23 Percentage of Participants
|
30 Percentage of Participants
|
38 Percentage of Participants
|
31 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=28 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=32 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=31 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=32 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in UPDRS Parts II and III Combined
|
-2.88 Scores on a scale
Interval -5.87 to 0.1
|
-1.81 Scores on a scale
Interval -6.18 to 2.57
|
-3.81 Scores on a scale
Interval -6.76 to -0.85
|
-5.63 Scores on a scale
Interval -8.44 to -2.81
|
-6.62 Scores on a scale
Interval -9.51 to -3.72
|
-3.87 Scores on a scale
Interval -8.68 to 0.94
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=27 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=11 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=28 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=28 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=7 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in UPDRS Activities of Daily Living
|
-0.26 Score on a scale
Interval -1.23 to 0.72
|
0.91 Score on a scale
Interval -0.58 to 2.41
|
-0.73 Score on a scale
Interval -1.74 to 0.27
|
-1.13 Score on a scale
Interval -2.08 to -0.17
|
-1.27 Score on a scale
Interval -2.32 to -0.22
|
-0.99 Score on a scale
Interval -2.77 to 0.79
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=28 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=32 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=31 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=32 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Total UPDRS Score (Parts I-III)
|
-2.74 Score on a scale
Interval -5.79 to 0.31
|
-2.18 Score on a scale
Interval -6.65 to 2.29
|
-3.83 Score on a scale
Interval -6.85 to -0.81
|
-5.93 Score on a scale
Interval -8.8 to -3.06
|
-6.68 Score on a scale
Interval -9.64 to -3.71
|
-3.40 Score on a scale
Interval -8.3 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the "on" phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=33 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=33 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=34 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=10 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the UPDRS Part I (Mentation)
|
0.05 Score on a scale
Interval -0.24 to 0.34
|
-0.34 Score on a scale
Interval -0.78 to 0.1
|
-0.01 Score on a scale
Interval -0.31 to 0.28
|
-0.26 Score on a scale
Interval -0.54 to 0.02
|
-0.02 Score on a scale
Interval -0.31 to 0.27
|
0.50 Score on a scale
Interval 0.02 to 0.98
|
SECONDARY outcome
Timeframe: Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=40 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=40 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=40 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=39 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale
|
20 Percentage of participants
|
15 Percentage of participants
|
28 Percentage of participants
|
45 Percentage of participants
|
56 Percentage of participants
|
23 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed
The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=40 Participants
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=40 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=40 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=39 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=13 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
|
5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Treatment Group A: Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Treatment Group B: 2 mg/Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Group C: 4 mg/Day
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment Group D: 8 mg/Day
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Treatment Group E: 12 mg/Day
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment Group F: 24 mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group A: Placebo
n=40 participants at risk
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=41 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=40 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=39 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=13 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
General disorders
Chest pain
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
Other adverse events
| Measure |
Treatment Group A: Placebo
n=40 participants at risk
Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 2 mg/Day
n=13 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 4 mg/Day
n=41 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 8 mg/Day
n=40 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 12 mg/Day
n=39 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=13 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
12.2%
5/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
9.8%
4/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Sudden onset of sleep
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
14.6%
6/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
32.5%
13/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
4.9%
2/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
15.4%
2/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Investigations
Blood creatine
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Psychiatric disorders
Abnormal dreams
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
General disorders
Asthenia
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.4%
1/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/41 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
7.7%
1/13 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 28 weeks)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the study treatment. A SAE results in death, is life-threatening, requires hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER