Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N159 PBO/LEV | Experimental | Subjects had previously participated in study N159 in which they had received Placebo (PBO). |
|
| N159 LEV/LEV | Experimental | Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). |
|
| N01010+N151 LEV/LEV | Experimental | Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). |
|
| N01052 LEV/LEV | Experimental | Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the Treatment Period (an average of 2 years), compared to Baseline |
| 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. | During the Treatment Period (an average of 2 years), compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant Flow refers to the Intention-to-treat (ITT) Set.
The study started to enroll patients in February 1998 and concluded in January 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | N159 PBO/LEV | Subjects had previously participated in study N159 in which they had received Placebo (PBO). |
| FG001 | N159 LEV/LEV | Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). |
| FG002 | N01010+N151 LEV/LEV | Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). |
| FG003 | N01052 LEV/LEV | Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics refer to the Intention-to-treat (ITT) Set which consisted of all subjects who took at least one dose of levetiracetam in study N157 excluding subjects from one site due to the unreliability of the data reported.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | N159 PBO/LEV | Subjects had previously participated in study N159 in which they had received Placebo (PBO). |
| BG001 | N159 LEV/LEV | Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of change | During the Treatment Period (an average of 2 years), compared to Baseline |
|
Adverse events were collected from first dose in N157 to End of the Study (up to 7.5 years)
Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N159 PBO/LEV | Subjects had previously participated in study N159 in which they had received Placebo (PBO). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | Other | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Other | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
Not provided
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| During the Treatment Period (an average of 2 years), compared to Baseline |
| 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. | During the Treatment Period (an average of 2 years), compared to Baseline |
| 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). | 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 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. | During the Treatment Period (an average of 2 years), compared to Baseline |
| 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. | During the Treatment Period (an average of 2 years) |
| 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. | Day 0 (beginning day of the maintenance phase) |
| 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. | Day 1 - <= 2 months of the Maintenance Phase |
| 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. | > 2 months - <= 4 months of the Maintenance Phase |
| 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. | > 4 months - <= 6 months of the Maintenance Phase |
| 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. | > 6 months - <= 8 months of the Maintenance Phase |
| 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. | > 8 months - <= 10 months of the Maintenance Phase |
| 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. | > 10 months - <= 12 months of the Maintenance Phase |
| 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. | > 12 months - <= 14 months of the Maintenance Phase |
| 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. | > 14 months - <= 16 months of the Maintenance Phase |
| 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. | > 16 months - <= 18 months of the Maintenance Phase |
| 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. | > 18 months - <= 20 months of the Maintenance Phase |
| 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 | During the Treatment Period (an average of 2 years) |
| 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. | Visit 1 (Screening Visit (Week 0)) |
| 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). | Titration Visit 1 (Week 2) |
| 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). | Titration Visit 2 (Week 4) |
| 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). | Titration Visit 3 (Week 6) |
| 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). | Visit 2 (Month 2) |
| 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). | Visit 3 (Month 4) |
| 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). | Visit 4 (Month 6) |
| 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). | Visit 5 (Month 9) |
| 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). | Visit 6 (Month 12) |
| 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). | Visit 7 (Month 15) |
| 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). | Visit 8 (Month 18) |
| 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). | Visit 9 (Month 21) |
| 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). | Visit 10 (Month 24) |
| 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). | Visit 11 (Month 27) |
| 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). | Visit 12 (Month 30) |
| 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). | Visit 13 (Month 33) |
| 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). | Visit 14 (Month 36) |
| 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). | Visit 15 (Month 39) |
| 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). | Visit 16 (Month 42) |
| 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). | Visit 17 (Month 45) |
| 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). | Visit 18 (Month 48) |
| 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). | Visit 19 (Month 51) |
| 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). | Visit 20 (Month 54) |
| 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). | Visit 21 (Month 57) |
| 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). | Visit 22 (Month 60) |
| 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). | Visit 23 (Month 63) |
| 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). | Visit 24 (Month 66) |
| 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). | Visit 25 (Month 69) |
| 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). | Visit 26 (Month 72) |
| 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). | Visit 27 (Month 75) |
| 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). | Visit 28 (Month 78) |
| 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). | Visit 29 (Month 81) |
| 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). | Visit 30 (Month 84) |
| 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). | Visit 31 (Month 87) |
| 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). | Withdrawal visit (up to Month 90) |
| 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). | Final visit (up to Month 90) |
| 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. | Visit 1 (Screening Visit (Week 0)) |
| 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). | Titration Visit 1 (Week 2) |
| 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). | Titration Visit 2 (Week 4) |
| 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). | Titration Visit 3 (Week 6) |
| 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). | Visit 2 (Month 2) |
| 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). | Visit 3 (Month 4) |
| 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). | Visit 4 (Month 6) |
| 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). | Visit 5 (Month 9) |
| 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). | Visit 6 (Month 12) |
| 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). | Visit 7 (Month 15) |
| 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). | Visit 8 (Month 18) |
| 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). | Visit 9 (Month 21) |
| 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). | Visit 10 (Month 24) |
| 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). | Visit 11 (Month 27) |
| 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). | Visit 12 (Month 30) |
| 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). | Visit 13 (Month 33) |
| 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). | Visit 14 (Month 36) |
| 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). | Visit 15 (Month 39) |
| 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). | Visit 16 (Month 42) |
| 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). | Visit 17 (Month 45) |
| 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). | Visit 18 (Month 48) |
| 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). | Visit 19 (Month 51) |
| 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). | Visit 20 (Month 54) |
| 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). | Visit 21 (Month 57) |
| 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). | Visit 22 (Month 60) |
| 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). | Visit 23 (Month 63) |
| 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). | Visit 24 (Month 66) |
| 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). | Visit 25 (Month 69) |
| 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). | Visit 26 (Month 72) |
| 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). | Visit 27 (Month 75) |
| 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). | Visit 28 (Month 78) |
| 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). | Visit 29 (Month 81) |
| 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). | Visit 30 (Month 84) |
| 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). | Visit 31 (Month 87) |
| 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). | Withdrawal visit (up to Month 90) |
| 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). | Final visit (up to Month 90) |
| Adverse Event |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Sponsor decision |
|
| Site/Investigator discontinued the study |
|
| Decision of parent(s) |
|
| Decision of parent(s) and investigator |
|
| Loss/ incompleteness of efficacy |
|
| Investigator decision |
|
| Subject relocated |
|
| Subject continues Keppra through prescriptions |
|
| Convenience |
|
| Subject entered new drug study |
|
| Subject to undergo surgery for seizures |
|
| Lack of ease of swallowing |
|
| BG002 | N01010+N151 LEV/LEV | Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). |
| BG003 | N01052 LEV/LEV | Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). |
| BG004 | Total Title |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| N159 PBO/LEV |
Subjects had previously participated in study N159 in which they had received Placebo (PBO). |
| OG001 | N159 LEV/LEV | Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). |
| OG002 | N01010+N151 LEV/LEV | Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). |
| OG003 | N01052 LEV/LEV | Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). |
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of change | During the Treatment Period (an average of 2 years), compared to Baseline |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | partial seizure frequency per week | During the Treatment Period (an average of 2 years), compared to Baseline |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | partial seizure frequency per week | During the Treatment Period (an average of 2 years), compared to Baseline |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | During the Treatment Period (an average of 2 years), compared to Baseline |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | During the Treatment Period (an average of 2 years), compared to Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | During the Treatment Period (an average of 2 years) |
|
|
|
| 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. | Posted | Number | percentage of participants | Day 0 (beginning day of the maintenance phase) |
|
|
|
| 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. | Posted | Number | percentage of participants | Day 1 - <= 2 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 2 months - <= 4 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 4 months - <= 6 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 6 months - <= 8 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 8 months - <= 10 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 10 months - <= 12 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 12 months - <= 14 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 14 months - <= 16 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 16 months - <= 18 months of the Maintenance Phase |
|
|
|
| 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. | Posted | Number | percentage of participants | > 18 months - <= 20 months of the Maintenance Phase |
|
|
|
| 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 | Posted | Number | seizures | During the Treatment Period (an average of 2 years) |
|
|
|
| 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. | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 1 (Screening Visit (Week 0)) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 1 (Week 2) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 2 (Week 4) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 3 (Week 6) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 2 (Month 2) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 3 (Month 4) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 4 (Month 6) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 5 (Month 9) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 6 (Month 12) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 7 (Month 15) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 8 (Month 18) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 9 (Month 21) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 10 (Month 24) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 11 (Month 27) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 12 (Month 30) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 13 (Month 33) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 14 (Month 36) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 15 (Month 39) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 16 (Month 42) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 17 (Month 45) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 18 (Month 48) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 19 (Month 51) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 20 (Month 54) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 21 (Month 57) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 22 (Month 60) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 23 (Month 63) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 24 (Month 66) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 25 (Month 69) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 26 (Month 72) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 27 (Month 75) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 28 (Month 78) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 29 (Month 81) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 30 (Month 84) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 31 (Month 87) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Withdrawal visit (up to Month 90) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Final visit (up to Month 90) |
|
|
|
| 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. | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 1 (Screening Visit (Week 0)) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 1 (Week 2) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 2 (Week 4) |
|
|
|
| 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). | 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. | Posted | Number | percentage of participants | Titration Visit 3 (Week 6) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 2 (Month 2) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 3 (Month 4) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 4 (Month 6) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 5 (Month 9) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 6 (Month 12) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 7 (Month 15) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 8 (Month 18) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 9 (Month 21) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 10 (Month 24) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 11 (Month 27) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 12 (Month 30) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 13 (Month 33) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 14 (Month 36) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 15 (Month 39) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 16 (Month 42) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 17 (Month 45) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 18 (Month 48) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 19 (Month 51) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 20 (Month 54) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 21 (Month 57) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 22 (Month 60) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 23 (Month 63) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 24 (Month 66) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 25 (Month 69) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 26 (Month 72) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 27 (Month 75) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 28 (Month 78) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 29 (Month 81) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 30 (Month 84) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Visit 31 (Month 87) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Withdrawal visit (up to Month 90) |
|
|
|
| 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). | Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. | Posted | Number | percentage of participants | Final visit (up to Month 90) |
|
|
|
| 0 |
| 79 |
| 20 |
| 79 |
| 77 |
| 79 |
| EG001 | N159 LEV/LEV | Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). | 1 | 89 | 35 | 89 | 86 | 89 |
| EG002 | N01010+N151 LEV/LEV | Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). | 0 | 41 | 12 | 41 | 41 | 41 |
| EG003 | N01052 LEV/LEV | Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV). | 0 | 14 | 7 | 14 | 13 | 14 |
| Cyst | General disorders | Other | Non-systematic Assessment |
|
| Fever | General disorders | Other | Non-systematic Assessment |
|
| Hypothermia | General disorders | Other | Non-systematic Assessment |
|
| Infection | General disorders | Other | Non-systematic Assessment |
|
| Infection bacterial | General disorders | Other | Non-systematic Assessment |
|
| Overdose | General disorders | Other | Non-systematic Assessment |
|
| Reaction unevaluable | General disorders | Other | Non-systematic Assessment |
|
| Heart arrest | Cardiac disorders | Other | Non-systematic Assessment |
|
| Hemorrhage | Cardiac disorders | Other | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Fecal impaction | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Gasteroenteritis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Ileitis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Increased salivation | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Stomach atony | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | Other | Non-systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | Other | Non-systematic Assessment |
|
| Albuminuria | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Musculoskeletal congenital anomaly | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Myasthenia | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Antisocial reaction | Nervous system disorders | Other | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | Other | Non-systematic Assessment |
|
| Apathy | Nervous system disorders | Other | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | Other | Non-systematic Assessment |
|
| Depression | Nervous system disorders | Other | Non-systematic Assessment |
|
| Intracranial hypertension | Nervous system disorders | Other | Non-systematic Assessment |
|
| Nervousness | Nervous system disorders | Other | Non-systematic Assessment |
|
| Personality disorder | Nervous system disorders | Other | Non-systematic Assessment |
|
| Psychosis | Nervous system disorders | Other | Non-systematic Assessment |
|
| Pschychotic depression | Nervous system disorders | Other | Non-systematic Assessment |
|
| Schizophrenic reaction | Nervous system disorders | Other | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Other | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | Other | Non-systematic Assessment |
|
| Status epilepticus partial | Nervous system disorders | Other | Non-systematic Assessment |
|
| Procedure diagnostic epilepsy | Investigations | Other | Non-systematic Assessment |
|
| Procedure diagnostic | Investigations | Other | Non-systematic Assessment |
|
| Procedure therapeutic epilepsy | Investigations | Other | Non-systematic Assessment |
|
| Procedure therapeutic | Investigations | Other | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Kidney calculus | Renal and urinary disorders | Other | Non-systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | Other | Non-systematic Assessment |
|
| Urogenital disorder | Renal and urinary disorders | Other | Non-systematic Assessment |
|
| Accidental injury | General disorders | Other | Non-systematic Assessment |
|
| Allergic reaction | General disorders | Other | Non-systematic Assessment |
|
| Asthenia | General disorders | Other | Non-systematic Assessment |
|
| Drug level increased | General disorders | Other | Non-systematic Assessment |
|
| Fever | General disorders | Other | Non-systematic Assessment |
|
| Flu syndrome | General disorders | Other | Non-systematic Assessment |
|
| Headache | General disorders | Other | Non-systematic Assessment |
|
| Hostility | General disorders | Other | Non-systematic Assessment |
|
| Infection | General disorders | Other | Non-systematic Assessment |
|
| Infection fungal | General disorders | Other | Non-systematic Assessment |
|
| Pain | General disorders | Other | Non-systematic Assessment |
|
| Sepsis | General disorders | Other | Non-systematic Assessment |
|
| Viral infection | General disorders | Other | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Cardiac disorders | Other | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Gamma glutamyl transpeptidase increased | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Hemorrhagic gastritis | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Increased salivation | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Accerlerated sexual maturity | Endocrine disorders | Other | Non-systematic Assessment |
|
| Ecchymosis | Blood and lymphatic system disorders | Other | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Other | Non-systematic Assessment |
|
| Creatine phosphokinase increased | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Sgot increased | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | Other | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Myasthenia | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Strabismus | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Agitation | Nervous system disorders | Other | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | Other | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | Other | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | Other | Non-systematic Assessment |
|
| CNS congenital anomaly | Nervous system disorders | Other | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | Other | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | Other | Non-systematic Assessment |
|
| Depression | Nervous system disorders | Other | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Other | Non-systematic Assessment |
|
| Emotional lability | Nervous system disorders | Other | Non-systematic Assessment |
|
| Hyperkinesia | Nervous system disorders | Other | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Other | Non-systematic Assessment |
|
| Nervousness | Nervous system disorders | Other | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Other | Non-systematic Assessment |
|
| Personality disorder | Nervous system disorders | Other | Non-systematic Assessment |
|
| Psychosis | Nervous system disorders | Other | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Other | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | Other | Non-systematic Assessment |
|
| Thinking abnormal | Nervous system disorders | Other | Non-systematic Assessment |
|
| Procedure therapeutic | Investigations | Other | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Cough increased | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Other | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Maculopapular rash | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Other | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Other | Non-systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | Other | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Other | Non-systematic Assessment |
|
| Otitis media | Ear and labyrinth disorders | Other | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Other | Non-systematic Assessment |
|
| Urine abnormability | Renal and urinary disorders | Other | Non-systematic Assessment |
|
Not provided
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Total Type I seizures |
|
| Total Type II seizures |
|
| Total Type III seizures |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worsening |
|
| Not done |
|