Epilepsy, Partial
Conditions
Keywords
Epilepsy, Pediatric, Partial onset epilepsy, Levetiracetam, Keppra
Brief summary
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.
Interventions
DRUGLevetiracetam
* Pharmaceutical form: Oral tablets and oral solution * Route of administration: Oral use
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®) * Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.
Exclusion criteria
* Not be on a ketogenic diet (during the course of this study). * Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline. |
| Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | At least 50% responder rate in Partial Onset (Type I) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in Partial Onset (Type I) seizure frequency of at least 50%. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) | > 8 months - <= 10 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | At least 50% responder rate in total (Type I, II, III) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in total (Type I, II, III) seizure frequency of at least 50%. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. |
| Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period | During the Treatment Period (an average of 2 years) | A day was considered seizure-free if no seizures were reported for 24 hours. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) | Day 0 (beginning day of the maintenance phase) | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) | Day 1 - <= 2 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) | > 10 months - <= 12 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) | > 2 months - <= 4 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) | > 4 months - <= 6 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) | > 6 months - <= 8 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) | > 12 months - <= 14 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) | > 14 months - <= 16 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) | > 16 months - <= 18 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) | > 18 months - <= 20 months of the Maintenance Phase | A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication. |
| Number of Seizures by Type During the Treatment Period | During the Treatment Period (an average of 2 years) | Number of following seizure types were assessed: Total seizures (Type I, II, III), Total Type I seizures, Total Type II seizures, Total Type III seizures |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Visit 1 (Screening Visit (Week 0)) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant. |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Titration Visit 1 (Week 2) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Titration Visit 2 (Week 4) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Titration Visit 3 (Week 6) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Visit 2 (Month 2) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Visit 3 (Month 4) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Visit 4 (Month 6) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Visit 5 (Month 9) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Visit 6 (Month 12) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Visit 7 (Month 15) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Visit 8 (Month 18) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Visit 9 (Month 21) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Visit 10 (Month 24) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Visit 11 (Month 27) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Visit 12 (Month 30) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Visit 13 (Month 33) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Visit 14 (Month 36) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Visit 15 (Month 39) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Visit 16 (Month 42) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Visit 17 (Month 45) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Visit 18 (Month 48) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Visit 19 (Month 51) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Visit 20 (Month 54) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Visit 21 (Month 57) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Visit 22 (Month 60) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Visit 23 (Month 63) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Visit 24 (Month 66) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Visit 25 (Month 69) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Visit 26 (Month 72) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Visit 27 (Month 75) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Visit 28 (Month 78) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Visit 29 (Month 81) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Visit 30 (Month 84) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Visit 31 (Month 87) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Withdrawal visit (up to Month 90) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Final visit (up to Month 90) | Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Visit 1 (Screening Visit (Week 0)) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant. |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Titration Visit 1 (Week 2) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Titration Visit 2 (Week 4) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Titration Visit 3 (Week 6) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Visit 2 (Month 2) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Visit 3 (Month 4) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Visit 4 (Month 6) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Visit 5 (Month 9) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Visit 6 (Month 12) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Visit 7 (Month 15) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Visit 8 (Month 18) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Visit 9 (Month 21) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Visit 10 (Month 24) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Visit 11 (Month 27) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Visit 12 (Month 30) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Visit 13 (Month 33) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Visit 14 (Month 36) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Visit 15 (Month 39) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Visit 16 (Month 42) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Visit 17 (Month 45) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Visit 18 (Month 48) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Visit 19 (Month 51) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Visit 20 (Month 54) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Visit 21 (Month 57) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Visit 22 (Month 60) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Visit 23 (Month 63) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | Absolute change from Baseline of Partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline. |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Visit 25 (Month 69) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Visit 26 (Month 72) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Visit 27 (Month 75) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Visit 28 (Month 78) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Visit 29 (Month 81) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Visit 30 (Month 84) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Visit 31 (Month 87) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Withdrawal visit (up to Month 90) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Final visit (up to Month 90) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Visit 24 (Month 66) | Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). |
| Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | During the Treatment Period (an average of 2 years), compared to Baseline | Absolute change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate improvement from Baseline. |
Participant flow
Recruitment details
The study started to enroll patients in February 1998 and concluded in January 2006.
Pre-assignment details
Participant Flow refers to the Intention-to-treat (ITT) Set.
Participants by arm
| Arm | Count |
|---|---|
| N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO). | 79 |
| N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). | 89 |
| N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). | 41 |
| N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). | 14 |
| Total Title | 223 |
| Total | 446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 2 | 2 | 3 |
| Overall Study | Convenience | 0 | 1 | 0 | 0 |
| Overall Study | Decision of parent(s) | 1 | 2 | 0 | 0 |
| Overall Study | Decision of parent(s) and investigator | 3 | 0 | 0 | 0 |
| Overall Study | Investigator decision | 1 | 0 | 0 | 1 |
| Overall Study | Lack of ease of swallowing | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 6 | 11 | 9 | 0 |
| Overall Study | Loss/ incompleteness of efficacy | 12 | 12 | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 7 | 8 | 3 | 1 |
| Overall Study | Site/Investigator discontinued the study | 5 | 5 | 2 | 0 |
| Overall Study | Sponsor decision | 0 | 0 | 0 | 1 |
| Overall Study | Subject continues Keppra through prescriptions | 0 | 4 | 0 | 0 |
| Overall Study | Subject entered new drug study | 0 | 1 | 0 | 0 |
| Overall Study | Subject relocated | 2 | 2 | 1 | 0 |
| Overall Study | Subject to undergo surgery for seizures | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 10 | 5 | 0 |
Baseline characteristics
| Characteristic | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV | Total Title |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 79 Participants | 89 Participants | 41 Participants | 14 Participants | 223 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.88 years STANDARD_DEVIATION 3.46 | 10.61 years STANDARD_DEVIATION 3.24 | 10.07 years STANDARD_DEVIATION 2.2 | 1.62 years STANDARD_DEVIATION 1.16 | 9.68 years STANDARD_DEVIATION 3.72 |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 16 Participants | 7 Participants | 105 Participants |
| Sex: Female, Male Male | 36 Participants | 50 Participants | 25 Participants | 7 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 1 / 89 | 0 / 41 | 0 / 14 |
| other Total, other adverse events | 77 / 79 | 86 / 89 | 41 / 41 | 13 / 14 |
| serious Total, serious adverse events | 20 / 79 | 35 / 89 | 12 / 41 | 7 / 14 |
Outcome results
Primary
Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period
Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects with valid data for Partial (Type I) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N159 PBO/LEV | Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period | -66.4 percentage of change |
| N159 LEV/LEV | Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period | -47.8 percentage of change |
| N01010+N151 LEV/LEV | Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period | -66.4 percentage of change |
Primary
Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period
Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline.
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects with valid data for total (Type I, II, III) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N159 PBO/LEV | Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -66.4 percentage of change |
| N159 LEV/LEV | Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -45.7 percentage of change |
| N01010+N151 LEV/LEV | Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -65.9 percentage of change |
Secondary
Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period
Absolute change from Baseline of Partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects with valid data for Partial Onset (Type I) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N159 PBO/LEV | Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period | -2.1 partial seizure frequency per week |
| N159 LEV/LEV | Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period | -1.6 partial seizure frequency per week |
| N01010+N151 LEV/LEV | Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period | -1.5 partial seizure frequency per week |
Secondary
Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period
Absolute change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate improvement from Baseline.
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects with valid data for total (Type I, II, III) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N159 PBO/LEV | Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -2.1 partial seizure frequency per week |
| N159 LEV/LEV | Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -1.5 partial seizure frequency per week |
| N01010+N151 LEV/LEV | Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period | -1.1 partial seizure frequency per week |
Secondary
At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period
At least 50% responder rate in Partial Onset (Type I) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in Partial Onset (Type I) seizure frequency of at least 50%. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures).
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects who have a baseline greater than zero for partial onset (Type I) seizures and valid N157 seizure information are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period | 58.4 percentage of participants |
| N159 LEV/LEV | At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period | 47.7 percentage of participants |
| N01010+N151 LEV/LEV | At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period | 62.2 percentage of participants |
Secondary
At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period
At least 50% responder rate in total (Type I, II, III) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in total (Type I, II, III) seizure frequency of at least 50%. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification.
Time frame: During the Treatment Period (an average of 2 years), compared to Baseline
Population: Only subjects who have a baseline greater than zero for partial onset (Type I) seizures and valid N157 seizure information are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period | 58.4 percentage of participants |
| N159 LEV/LEV | At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period | 46.6 percentage of participants |
| N01010+N151 LEV/LEV | At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period | 62.2 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 10 months - <= 12 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) | 1.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) | 3.5 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) | 7.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 12 months - <= 14 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) | 1.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) | 2.3 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) | 5.0 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 14 months - <= 16 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) | 1.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) | 2.3 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) | 5.0 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 16 months - <= 18 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) | 1.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) | 2.3 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) | 2.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 18 months - <= 20 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) | 1.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) | 2.3 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) | 2.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 2 months - <= 4 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) | 12.3 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) | 12.8 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) | 17.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months) | 23.1 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 4 months - <= 6 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) | 11.0 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) | 9.3 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) | 15.0 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 6 months - <= 8 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) | 8.2 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) | 4.7 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) | 12.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: > 8 months - <= 10 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) | 5.5 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) | 3.5 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) | 10.0 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months) | 11.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: Day 0 (beginning day of the maintenance phase)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) | 74.0 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) | 64.0 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) | 75.0 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0) | 38.5 percentage of participants |
Secondary
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months)
A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.
Time frame: Day 1 - <= 2 months of the Maintenance Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N159 PBO/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) | 16.4 percentage of participants |
| N159 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) | 15.1 percentage of participants |
| N01010+N151 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) | 27.5 percentage of participants |
| N01052 LEV/LEV | Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months) | 23.1 percentage of participants |
Secondary
Number of Seizures by Type During the Treatment Period
Number of following seizure types were assessed: Total seizures (Type I, II, III), Total Type I seizures, Total Type II seizures, Total Type III seizures
Time frame: During the Treatment Period (an average of 2 years)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Number of Seizures by Type During the Treatment Period | Total seizures (Type I, II, III) | 42132 seizures |
| N159 PBO/LEV | Number of Seizures by Type During the Treatment Period | Total Type I seizures | 39147 seizures |
| N159 PBO/LEV | Number of Seizures by Type During the Treatment Period | Total Type II seizures | 2142 seizures |
| N159 PBO/LEV | Number of Seizures by Type During the Treatment Period | Total Type III seizures | 843 seizures |
| N159 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type I seizures | 57464 seizures |
| N159 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type II seizures | 12656 seizures |
| N159 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type III seizures | 1 seizures |
| N159 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total seizures (Type I, II, III) | 70121 seizures |
| N01010+N151 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type II seizures | 142 seizures |
| N01010+N151 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type I seizures | 24089 seizures |
| N01010+N151 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type III seizures | 1 seizures |
| N01010+N151 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total seizures (Type I, II, III) | 24232 seizures |
| N01052 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type III seizures | 0 seizures |
| N01052 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type I seizures | 13675 seizures |
| N01052 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total seizures (Type I, II, III) | 19914 seizures |
| N01052 LEV/LEV | Number of Seizures by Type During the Treatment Period | Total Type II seizures | 6239 seizures |
Secondary
Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period
A day was considered seizure-free if no seizures were reported for 24 hours.
Time frame: During the Treatment Period (an average of 2 years)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N159 PBO/LEV | Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period | 74 Participants |
| N159 LEV/LEV | Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period | 73 Participants |
| N01010+N151 LEV/LEV | Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period | 40 Participants |
| N01052 LEV/LEV | Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period | 10 Participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Final visit (up to Month 90)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 4.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 11.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 23.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 36.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 17.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 4.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 1.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 9.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 2.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 61.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 9.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 3.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 14.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 51.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 4.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 9.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 2.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 17.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 7.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 69.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 7.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 15.4 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 1 (Week 2)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 1 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked improvement | 14.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate improvement | 14.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight improvement | 32.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | No change | 33.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight worsening | 4.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Not done | 1.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked improvement | 6.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight worsening | 9.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate improvement | 14.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight improvement | 18.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate worsening | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | No change | 47.6 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 2 (Week 4)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 2 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked improvement | 10.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate improvement | 20.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight improvement | 20.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | No change | 37.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight worsening | 9.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate worsening | 2.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Not done | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked improvement | 13.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight worsening | 11.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate improvement | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight improvement | 15.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate worsening | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | No change | 46.4 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 3 (Week 6)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 3 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked improvement | 10.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate improvement | 14.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight improvement | 17.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | No change | 41.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight worsening | 7.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate worsening | 4.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Not done | 3.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Not done | 2.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked improvement | 4.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight worsening | 9.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate improvement | 8.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked worsening | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight improvement | 21.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate worsening | 4.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | No change | 47.9 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.
Time frame: Visit 1 (Screening Visit (Week 0))
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 21.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 12.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 47.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 5.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 3.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 1.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 5.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 18.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 40.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 24.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 11.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 19.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 26.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 12.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 29.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 12.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 100.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 10 (Month 24)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 5.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 8.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 22.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 45.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 11.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 5.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 12.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 12.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 51.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 17.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 6.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 48.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 4.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 8.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 66.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 16.7 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 11 (Month 27)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 9.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 9.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 21.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 50.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 6.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 3.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 4.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 15.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 6.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 2.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 2.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 45.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 20.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 2.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 13.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 54.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 4.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 4.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 22.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 60.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 12 (Month 30)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 16.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 3.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 2.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 43.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 25.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 5.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 61.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 5.6 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 75.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 13 (Month 33)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 3.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 34.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 15.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 3.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 6.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 46.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 23.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 3.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 22.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 55.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 50.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 50.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 14 (Month 36)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 13.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 40.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 13.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 45.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 25.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 4.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 66.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 15 (Month 39)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 26.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 46.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 13.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 28.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 61.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 9.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 57.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 16 (Month 42)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 35.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 42.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 14.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 7.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 11.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 5.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 61.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 5.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 85.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 17 (Month 45)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 53.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 17.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 47.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 23.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 11.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 83.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 18 (Month 48)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 15.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 46.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 30.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 30.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 38.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 50.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 19 (Month 51)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 18.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 54.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 18.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 46.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 23.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 40.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 2 (Month 2)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 4.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 15.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 26.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 34.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 15.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 2.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 1.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 14.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 46.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 17.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 8.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 25.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 28.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 2.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 2.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 20.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 20.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 8.3 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 20 (Month 54)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 18.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 63.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 58.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 21 (Month 57)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 55.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 12.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 62.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 12.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 12.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 80.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 22 (Month 60)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 75.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 25.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 23 (Month 63)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 50.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 50.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 40.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 24 (Month 66)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | No change | 100.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | No change | 80.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 25 (Month 69)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 26 (Month 72)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Moderate improvement | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 27 (Month 75)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Moderate improvement | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 28 (Month 78)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 29 (Month 81)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Slight worsening | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 3 (Month 4)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 4.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 7.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 20.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 41.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 20.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 3.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 20.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 3.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 50.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 14.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 6.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 26.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 34.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 7.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 15.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 15.8 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 30.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 40.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 30 (Month 84)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 31 (Month 87)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 4 (Month 6)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 4.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 6.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 23.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 42.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 12.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 7.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 1.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 4.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 17.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 10.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 1.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 34.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 28.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 4.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 8.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 42.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 2.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 17.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 60.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 5 (Month 9)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 3.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 13.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 25.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 35.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 18.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 3.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 4.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 16.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 1.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 46.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 18.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 6.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 9.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 53.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 12.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 6.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 3.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 15.6 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 22.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 44.4 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 22.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 11.1 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 6 (Month 12)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 5.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 16.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 29.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 20.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 3.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 1.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 6.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 18.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 13.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 41.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 19.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 1.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 17.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 39.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 10.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 14.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 22.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 55.6 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 7 (Month 15)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 12.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 4.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 23.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 42.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 12.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 2.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 2.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 1.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 21.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 13.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 1.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 40.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 11.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 9.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 39.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 10.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 7.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 37.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 37.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 12.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 12.5 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 8 (Month 18)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 10.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 5.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 20.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 37.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 25.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 2.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 3.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 17.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 11.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 39.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 23.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 3.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 42.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 7.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 17.9 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 66.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 9 (Month 21)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 48.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 5.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 12.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 23.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 2.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 18.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 14.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 8.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 34.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 22.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 2.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 22.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 33.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 7.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 7.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 14.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 3.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 80.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit
Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Withdrawal visit (up to Month 90)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 41.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 11.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 23.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 35.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 7.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 7.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 50.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 75.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Final visit (up to Month 90)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 8.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 14.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 15.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 17.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 5.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 2.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 34.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 58.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 7.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 3.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 8.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 13.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 1.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 1.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 7.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 4.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 4.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 12.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 51.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 4.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 14.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | No change | 69.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight worsening | 15.4 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Moderate worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Marked improvement | 7.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit | Slight improvement | 7.7 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 1 (Week 2)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 1 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked improvement | 17.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate improvement | 18.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight improvement | 32.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | No change | 25.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight worsening | 4.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Not done | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Not done | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked improvement | 11.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight worsening | 8.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate improvement | 11.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Slight improvement | 17.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | Moderate worsening | 1.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 | No change | 48.8 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 2 (Week 4)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 2 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked improvement | 17.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate improvement | 16.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight improvement | 20.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | No change | 36.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight worsening | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate worsening | 2.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Not done | 1.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Not done | 1.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight worsening | 15.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate improvement | 10.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Slight improvement | 15.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | Moderate worsening | 1.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 | No change | 39.3 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Titration Visit 3 (Week 6)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 3 was required only for subjects previously enrolled in N159.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked improvement | 10.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate improvement | 9.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight improvement | 20.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | No change | 43.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight worsening | 9.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate worsening | 3.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked worsening | 1.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Not done | 3.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Not done | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked improvement | 4.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight worsening | 8.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate improvement | 12.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Marked worsening | 1.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Slight improvement | 27.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | Moderate worsening | 4.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 | No change | 41.1 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.
Time frame: Visit 1 (Screening Visit (Week 0))
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 12.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 16.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 17.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 41.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 3.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 7.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 15.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 1.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 38.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 19.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 18.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 14.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 24.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 17.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 29.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 14.6 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | No change | 92.9 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Slight worsening | 7.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 10 (Month 24)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 8.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 5.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 22.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 42.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 11.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 5.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 2.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 2.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 10.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 8.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 48.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 21.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 8.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 4.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 40.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 12.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 4.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | No change | 66.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 | Moderate worsening | 16.7 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 11 (Month 27)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 9.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 9.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 18.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 53.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 6.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 3.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 6.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 11.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 4.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 2.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 2.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 45.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 18.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 9.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 9.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 54.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 4.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 9.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 22.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | No change | 40.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Slight worsening | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 12 (Month 30)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 13.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 26.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 16.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 3.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 2.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 5.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 12.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 2.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 48.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 20.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 7.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 5.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 55.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | No change | 75.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 13 (Month 33)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 23.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 15.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 15.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 3.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 6.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 46.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 23.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 3.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 22.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 55.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | No change | 75.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 14 (Month 36)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 20.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 26.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 40.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 13.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 12.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 4.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 50.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 20.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 4.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 4.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 4.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight improvement | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | No change | 66.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Slight worsening | 22.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 15 (Month 39)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 40.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 40.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 6.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 28.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 52.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 9.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 4.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 4.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | No change | 57.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 16 (Month 42)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 7.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 21.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 14.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 35.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 14.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 7.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 5.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 55.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 22.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight improvement | 28.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | No change | 71.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 17 (Month 45)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 15.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 46.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 23.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 41.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 17.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 5.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 11.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | No change | 83.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 18 (Month 48)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 23.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 38.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 23.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 38.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked improvement | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | No change | 50.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Moderate worsening | 16.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 19 (Month 51)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 27.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 45.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 18.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 23.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 38.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 23.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight improvement | 40.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | No change | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 2 (Month 2)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 30.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 6.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 17.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 21.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 17.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 2.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 2.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 4.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 4.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 11.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 2.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 13.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 45.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 1.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 15.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 20.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 17.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 17.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 2.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 25.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate improvement | 8.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | No change | 8.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight improvement | 41.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked worsening | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Marked improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 | Moderate worsening | 8.3 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 20 (Month 54)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 63.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 9.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 16.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 66.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 8.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 21 (Month 57)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 55.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 37.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 50.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 12.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | No change | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 22 (Month 60)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 75.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 25.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | No change | 60.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 23 (Month 63)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 50.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 50.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 100.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | No change | 40.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Moderate worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 24 (Month 66)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | No change | 100.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 | No change | 80.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 25 (Month 69)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 26 (Month 72)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Moderate improvement | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 27 (Month 75)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Moderate improvement | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 28 (Month 78)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 | Slight worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 29 (Month 81)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | No change | 75.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Slight worsening | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 3 (Month 4)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 8.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 16.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 38.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 19.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 10.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 1.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 3.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 22.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 6.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 48.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 13.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 6.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 18.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 36.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 7.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 2.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 18.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 15.8 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | No change | 30.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Slight worsening | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 30 (Month 84)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 31 (Month 87)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Moderate improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Slight improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | No change | 100.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Slight worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Moderate worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 | Not done | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 4 (Month 6)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 4.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 7.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 22.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 39.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 19.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 4.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 1.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 5.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 17.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 6.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 33.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 29.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 8.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 5.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 37.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 17.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 5.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 14.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | No change | 50.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked improvement | 20.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Slight worsening | 10.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 5 (Month 9)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 6.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 10.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 25.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 33.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 20.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 3.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 6.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 3.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 46.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 12.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 10.8 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 9.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 50.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 9.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 12.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 9.4 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 9.4 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | No change | 33.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate improvement | 33.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 | Moderate worsening | 11.1 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 6 (Month 12)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 7.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 9.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 25.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 33.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 18.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 3.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 1.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 8.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 11.5 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 13.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 1.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 34.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 23.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 8.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 39.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 14.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight improvement | 22.2 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | No change | 55.6 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked improvement | 11.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 7 (Month 15)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 10.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 10.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 23.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 29.8 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 19.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 4.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 2.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 3.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 15.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 9.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 1.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 1.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 40.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 7.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 19.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 10.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 42.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 25.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 3.6 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 7.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 7.1 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight improvement | 37.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | No change | 37.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Slight worsening | 12.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Marked worsening | 12.5 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 8 (Month 18)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 5.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 7.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 17.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 45.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 22.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 2.5 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 3.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 15.7 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 9.8 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 2.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 35.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 17.6 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 15.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 14.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 42.9 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 10.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 10.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 7.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 14.3 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | No change | 66.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked improvement | 16.7 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 | Moderate worsening | 0.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Visit 9 (Month 21)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 10.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 7.7 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 10.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 56.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 10.3 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 5.1 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 2.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 6.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 10.2 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 2.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 53.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 14.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 12.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 3.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 22.2 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 33.3 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 3.7 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 11.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 18.5 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 7.4 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight improvement | 40.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | No change | 40.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 | Moderate worsening | 20.0 percentage of participants |
Secondary
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit
Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).
Time frame: Withdrawal visit (up to Month 90)
Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 5.9 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 41.2 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 29.4 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 17.6 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 0.0 percentage of participants |
| N159 PBO/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 14.3 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 21.4 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 7.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 7.1 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 42.9 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 0.0 percentage of participants |
| N159 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 7.1 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 40.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 20.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 0.0 percentage of participants |
| N01010+N151 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight improvement | 25.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | No change | 75.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked improvement | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Slight worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Not done | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Marked worsening | 0.0 percentage of participants |
| N01052 LEV/LEV | Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit | Moderate worsening | 0.0 percentage of participants |