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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02408549
Registration number
NCT02408549
Ethics application status
Date submitted
31/03/2015
Date registered
3/04/2015
Titles & IDs
Public title
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
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Scientific title
An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
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Secondary ID [1]
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2012-001770-29
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Secondary ID [2]
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EP0012
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Universal Trial Number (UTN)
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Trial acronym
VALUE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide Tablet
Treatment: Drugs - Lacosamide Oral Solution
Experimental: Lacosamide - Start dose
SP0982 completers at V1:
* LCM 10 mg/kg/day for pediatric subjects weighing \<30 kg
* LCM 8 mg/kg/day for pediatric subjects weighing = 30kg to \<50 kg
* LCM 400 mg/day (200 mg bid) for adult subjects (=18 years of age) or pediatric subjects weighing =50 kg
SP0982 Baseline failures at V1:
* LCM 2 mg/kg/day for pediatric subjects weighing \<50 kg
* LCM 100 mg/day (50 mg bid) for adult subjects (=18 years of age) or pediatric subjects weighing =50 kg
Oral solution (pediatric subjects \<50 kg):
* Minimum LCM dose: 4 mg/kg/day
* Maximum LCM dose: 12 mg/kg/day
Tablets (pediatric subjects =50kg):
* Minimum LCM dose: 200 mg/day
* Minimum LCM dose: 600 mg/day
Tablets (adult subjects):
* Minimum LCM dose: 200 mg/day
* Maximum LCM dose: 800 mg/day
Treatment: Drugs: Lacosamide Tablet
* Active substance: Lacosamide
* Pharmaceutical form: Tablet
* Concentration: 50 mg and 100 mg
* Route of Administration: Oral administration
Treatment: Drugs: Lacosamide Oral Solution
* Active substance: Lacosamide
* Pharmaceutical form: Oral solution
* Concentration: 10 mg/ml
* Route of Administration: Oral administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
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Assessment method [1]
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AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
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Timepoint [1]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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Primary outcome [2]
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Number of Study Participants Withdrawn Due to TEAEs
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Assessment method [2]
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AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
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Timepoint [2]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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Primary outcome [3]
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Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
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Assessment method [3]
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The number of study participants with appearance of new absence and/or myoclonic seizure types experienced during the Treatment Period but who did not experience in Combined Baseline Period or in seizure classification history, before taking LCM were reported. To determine appearance of new seizure type, the Combined Baseline Period was used. Thus, the participants who directly enrolled into EP0012, the Baseline absence, and/or myoclonic seizure data from SP0982's 4-week Prospective Baseline Period were combined with any reported Baseline absence, and myoclonic seizure information in the daily seizure diary from EP0012 (reported before first dose in EP0012) to recalculate the study participant's Baseline variables such as days with absence, and/or myoclonic seizures per 28 days.
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Timepoint [3]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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Primary outcome [4]
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Number of Study Participants With an Increase of up to 25% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [4]
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The number of participants experiencing an increase of up to 25% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [4]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [5]
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Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [5]
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The number of participants experiencing an increase of \>25% to 50% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [5]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [6]
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Number of Study Participants With an Increase of >50% to 75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [6]
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The number of participants experiencing an increase of \>50% to 75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [6]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [7]
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Number of Study Participants With an Increase of >75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [7]
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The number of participants experiencing an increase of \>75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [7]
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0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [8]
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Number of Study Participants With an Increase of up to 25% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [8]
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The number of participants experiencing an increase of up to 25% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [8]
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0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [9]
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Number of Study Participants With an Increase of >25% to 50% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [9]
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The number of participants experiencing an increase of \>25% to 50% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [9]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [10]
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Number of Study Participants With an Increase of >50% to 75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [10]
0
0
The number of participants experiencing an increase of \>50% to 75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [10]
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0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [11]
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0
Number of Study Participants With an Increase of >75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
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Assessment method [11]
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The number of participants experiencing an increase of \>75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
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Timepoint [11]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
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Primary outcome [12]
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Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
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Assessment method [12]
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Seizure worsening was defined as a participant experiencing \>=50% increase in the number of days with absence seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of absence seizures in Prospective Baseline or the Treatment Period.
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Timepoint [12]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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Primary outcome [13]
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0
Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
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Assessment method [13]
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Seizure worsening was defined as a participant experiencing \>=50% increase in the number of days with myoclonic seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of myoclonic seizures in Prospective Baseline or the Treatment Period.
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Timepoint [13]
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From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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Secondary outcome [1]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
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Assessment method [1]
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TEMA values are defined in the Statistical Analysis Plan (SAP) as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Hematology parameter, Hemoglobin were those that were observed post-Baseline (BL) during the Treatment Period but not present at Baseline. For the age range, '2 years (y) to \<17 years', the abnormality criteria were '\<=95' grams/deciliter (g/dL) (Low) and '\>160' g/dL (High). For age range, '\>=17 years', the abnormality Criteria were '\<=85% of lower limit of normal (LLN)' value (Low) and '\>=115% of upper limit of normal (ULN)' value (High) of Hemoglobin in blood.
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Timepoint [1]
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During the study (up to approximately 5 years)
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Secondary outcome [2]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
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Assessment method [2]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Hematocrit were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '2 years to \<17 years', the abnormality criteria were '\<=29%' (Low) and '\>47%' (High) hematocrit values. For age range, '\>=17 years', the abnormality criteria were '\<=85% of LLN' (Low) and '\>=115% of ULN' (High) of Hematocrit values in blood.
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Timepoint [2]
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0
During the study (up to approximately 5 years)
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Secondary outcome [3]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
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Assessment method [3]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Platelet count were those that were observed post-BL during the Treatment Period but not present at BL. For the age range of '\>1 month', the abnormality criteria were '\<=100' 10\^9/L and '\>=600' 10\^9/L of Platelets count value.
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Timepoint [3]
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0
During the study (up to approximately 5 years)
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Secondary outcome [4]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
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Assessment method [4]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Erythrocytes parameter were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '\>=2years', the abnormality criteria were '\<3.5' 10\^12/L of Erythrocytes value in blood. Early Termination Visit (TV) was last visit in the study (up to approximately 5 years).
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Timepoint [4]
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0
During the study (up to approximately 5 years)
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Secondary outcome [5]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
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Assessment method [5]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Leukocytes were those that were observed post-BL during the Treatment Period but not present at BL. For all age ranges, the abnormality criteria were '\<=3.0' 10\^9/L (Low) and '\>= 16.0' 10\^9/L (High) of Leukocytes values in blood.
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Timepoint [5]
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0
During the study (up to approximately 5 years)
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Secondary outcome [6]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute)
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Assessment method [6]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Basophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '\>1 month', the abnormality criteria were '\>=0.4' 10\^9/L of Basophils in blood.
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Timepoint [6]
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0
During the study (up to approximately 5 years)
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Secondary outcome [7]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
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Assessment method [7]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Eosinophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '\>1 month', the abnormality criteria were '\>=1.0' 10\^9/L of Eosinophils in the blood.
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Timepoint [7]
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0
During the study (up to approximately 5 years)
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Secondary outcome [8]
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Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
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Assessment method [8]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Lymphocytes Absolute were those that were observed post-Baseline (BL) during the Treatment Period but not present at Baseline. For the age range, '2 years - \<6 years', the abnormality criteria were '\<0.7' 10\^9/L (Low) and '\>6.9' 10\^9/L (High). For age range, '\>=6 years', the abnormality criteria were '\<0.6' 10\^9/L (Low) and '\>5.0' 10\^9/L (High) for Lymphocytes Absolute in the blood.
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Timepoint [8]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [9]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Monocytes Absolute )
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Assessment method [9]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Monocytes Absolute were those that are observed post-BL during the Treatment Period but not present at BL. For the age range, '\>1 month', the abnormality criteria was '\>=2.0' 10\^9/L of Monocytes in blood.
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Timepoint [9]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [10]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
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Assessment method [10]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Neutrophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '\>1 month', the abnormality criteria was '\<1.5' 10\^9/L of Neutrophils in blood.
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Timepoint [10]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [11]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Calcium)
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Assessment method [11]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Calcium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year -\<17 years', the abnormality criteria were '\<=1.85' millimoles per litre (mmol/L) and '\>=2.95' mmol/L. For age range, '\>=17 years', the abnormality criteria was '\<=1.9 mmol/L' and '\>=2.75 mmol/L' of serum Calcium.
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Timepoint [11]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [12]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Sodium)
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Assessment method [12]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Sodium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>1 month', the abnormality criteria were '\<127' mmol/L (Low) and '\>151' mmol/L (High) of serum Sodium.
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Timepoint [12]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [13]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Potassium)
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Assessment method [13]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Potassium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>=1 year', the abnormality criteria were '\<= 3.0' mmol/L (Low) and '\>= 6.0' mmol/L (High) of serum Potassium.
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Timepoint [13]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [14]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
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Assessment method [14]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Chloride were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>1 month', the abnormality criteria were '\<=90' mmol/L (Low) and '\>=112' mmol/L (High) of serum Chloride.
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Timepoint [14]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [15]
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0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
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Assessment method [15]
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TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Bicarbonate were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>1 month-\<17 years', the abnormality criteria were '\<15' mmol/L (Low) and '\>38' mmol/L (High). For age range, '\>=17 years', the abnormality criteria were '\<18' mmol/L (Low) and '\>38' mmol/L (High) of serum Bicarbonate.
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Timepoint [15]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [16]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Creatinine)
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Assessment method [16]
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0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Creatinine were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1-\<10 years', the abnormality criteria were '\>106.8' micromole per litre (umol/L), for '10-\<16 years', the abnormality criteria were '\>159.12' umol/L and for '\>=16 years', the abnormality criteria was '\>=176.8' umol/L for serum Creatinine.
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Timepoint [16]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [17]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
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Assessment method [17]
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0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Aspartate Aminotransferase (AST) were those that were observed post- BL during the Treatment Period but not present at Baseline. For all ages, the abnormality criteria were specified as '=3.0 units per litre (U/L) x ULN' (High A), '=5.0 U/L x ULN' (High B), and '=10.0 U/L x ULN' (High C) of serum AST.
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Timepoint [17]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [18]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
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Assessment method [18]
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0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Alanine Aminotransferase (ALT) were those that were observed post- BL during the Treatment Period but not present at Baseline. For all ages, the abnormality criteria were specified as '=3.0 U/L x ULN' (High A), '=5.0 U/L x ULN' (High B), and '=10.0 U/L x ULN' (High C) of serum ALT.
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Timepoint [18]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [19]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Chemistry Parameters (Total Bilirubin)
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Assessment method [19]
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0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Total Bilirubin were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>1 month', the abnormality criteria was '=34.208' umol/L of serum Bilirubin.
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Timepoint [19]
0
0
During the study (up to approximately 5 years)
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Secondary outcome [20]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alkaline Phosphatase)
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Assessment method [20]
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0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Alkaline Phosphatase were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '4 years -\<10 years', the abnormality criteria was '\>=834 U/L', for '10 years -\<17 years', the abnormality criteria was '\>=1761 U/L' and for '\>=17 years', the abnormality criteria was '\>=3.0 U/L x ULN' of serum alkaline phosphatase.
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Timepoint [20]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [21]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
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Assessment method [21]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Gamma Glutamyl Transferase (GGT) were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year-\<13 years', the abnormality criteria was '\>=66' U/L (High A), for '13 years-\<17 years', the abnormality criteria was '\>=126' U/L (High B) and for '\>=17 years', the abnormality criteria was '\>=3.0 U/L x ULN' (High C) of serum GGT.
Query!
Timepoint [21]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [22]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Query!
Assessment method [22]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Glucose were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>1 month-\<17 years', the abnormality criteria were from '\<2.775' mmol/L (Low) and '\>=9.99' mmol/L (High). For age range, '\>=17 years', the abnormality criteria were '\<2.775' mmol/L (Low) and '\>=11.1' mmol/L (High) of serum Glucose.
Query!
Timepoint [22]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [23]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Albumin)
Query!
Assessment method [23]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Albumin were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '\>=1 year to \<17 years', the abnormality criteria were '\<24' g/L and '\>84' g/L and for age range, '\>=17 years', the abnormality criteria was '\<26' g/L of serum albumin.
Query!
Timepoint [23]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [24]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Total Protein)
Query!
Assessment method [24]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Total Protein were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year to \<17 years', the abnormality criteria were '\<43' g/L and '\>120' g/L. For age range, '\>=17 years', the abnormality criteria were '\<43' g/L and '\>130' g/L of serum protein.
Query!
Timepoint [24]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [25]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
Query!
Assessment method [25]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Phosphate were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year-\<17 years', the abnormality criteria were from '\<0.5814' mmol/L (Low) and '\>2.3902' mmol/L (High). For age range, '\>=17 years', the abnormality Criteria were '\<=0.646' mmol/L (Low) and '\>=1.938' mmol/L (High) of serum phosphate.
Query!
Timepoint [25]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [26]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Query!
Assessment method [26]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QT interval parameter were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 month (m)-\<12 years', the abnormality criteria were '\>=500 milliseconds (ms)' (Abnormal (Abn) A). For age range, '\>=12 years', the abnormality criteria were '\>=500 ms' (Abn B) or '\>=60 ms increase from Baseline' (Abn C). The abnormality in QT interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Query!
Timepoint [26]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [27]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Query!
Assessment method [27]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QTc(F) interval were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range '3 years -\<12 years' and '\>=12 years- \<17 years', the abnormality criteria were from '\>440 ms' (Abn A) and '\>15% increase from Baseline' value (Abn B). For age range, '\>=17 years', the abnormality Criteria were '\>450 ms' (Abn C), '\>480 ms' (Abn D), '\>500 ms' (Abn E) or '\>=60 ms increase from Baseline' value (Abn F). The abnormality in QTc(F) interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Query!
Timepoint [27]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [28]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Query!
Assessment method [28]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QTc(B) interval were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range '3 years -\<12 years' and '\>=12 years- \<17 years', the abnormality criteria were '\>450 ms' (Abn A) and '\>15% increase from Baseline' value (Abn B). For age range, '\>=17 years', the abnormality criteria were '\>450 ms' (Abn C), '\>480 ms' (Abn D), '\>500 ms' (Abn E) or '\>=60 ms increase from Baseline' value (Abn F). The abnormality in QTc(B) interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Query!
Timepoint [28]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [29]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Query!
Assessment method [29]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of PR interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\>180 ms' (Abn A) and '\>25% increase from Baseline' value (Abn B). For the age range, '\>=12 years - \<17 years', the abnormality criteria were '\>200 ms' (Abn C) and '\>25% increase from Baseline' value (Abn D). For age range, '\>=17 years', the abnormality criteria were treatment-emergent values above '\>200 ms' (Abn E), '\>220 ms' (Abn F), or '\>250 ms' (Abn G).
Query!
Timepoint [29]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [30]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Query!
Assessment method [30]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QRS interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\>100 ms' (Abn A) and '\>25% increase from Baseline' value (Abn B). For the age range, '\>=12 years - \<17 years', the abnormality criteria were '\>110 ms' (Abn C) and '\>25% increase from Baseline' (Abn D). For age range, '\>=17 years', the abnormality criteria were treatment-emergent values above '\>100 ms' (Abn E), '\>120 ms' (Abn F), or '\>140 ms' (Abn G).
Query!
Timepoint [30]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [31]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Query!
Assessment method [31]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of Heart rate interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\<60 beats per minute (bpm)' (Abn A) and '\>130 bpm' (Abn B). For the age range, '\>=12 years', the abnormality criteria were '\<50 bpm' (Abn C) and '\>120 bpm' (Abn D).
Query!
Timepoint [31]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [32]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Query!
Assessment method [32]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA vital signs results of Pulse rate were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\<60 bpm' (Low) and '\>130 bpm' (High). For the age range, '12 years - \<17 years', the abnormality criteria were '\<=50 bpm' (Low) and '\>=120 bpm' (High). For the age range, '\>=17 years', the abnormality criteria were '\<=50 bpm and a decrease from Baseline of \>=15 bpm' (Low A), '\>=120 bpm and an increase from Baseline of \>=15 bpm' (High A), '\<60 bpm' (Low B) and '\>100 bpm' (High B). The Pulse rate was reported as per positions such as 'Supine 3 minute (Sup 3 min)', 'Standing 1 minute' (Std 1 min), and 'Standing 3 minute' (Std 3 min).
Query!
Timepoint [32]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [33]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Query!
Assessment method [33]
0
0
TEMA values of Systolic Blood Pressure (BP) results were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\<80 millimeters of mercury (mmHg)' (Low) and '\>140 mmHg' (High). For the age range, '\>=12 years - \<17 years', the abnormality criteria were '\<90 mmHg' (Low) and '\>160 mmHg' (High). For the age range, '\>=17 years', the abnormality criteria were '\<=90 mmHg and decrease from Baseline of \>=20 mmHg' (Low A), '\>=180 mmHg and increase from Baseline of \>=20' mmHg (High A), '\<90 mmHg' (Low B), '\>140 mmHg (High B), and '\>160 mmHg' (High C). Systolic BP were reported as per positions such as 'Sup 3 min', 'Std 1 min, and 'Std 3 min'.
Query!
Timepoint [33]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [34]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Query!
Assessment method [34]
0
0
TEMA values of Diastolic BP results were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -\<12 years', the abnormality criteria were '\<50 mmHg' (Low) and '\>80 mmHg' (High), '\>=12 years - \<17 years', the abnormality criteria were '\<=50 mmHg' (Low) and '\>=105 mmHg' (High), and '\>=17 years', the abnormality criteria were '\<=50 mmHg and decrease from Baseline of \>=15 mmHg' (Low A), '\>=105 mmHg and increase from Baseline of \>=15' mmHg (High A), '\<50 mmHg' (Low B), '\>90 mmHg' (High B), and '\>100 mmHg' (High C). Diastolic BP were reported as per positions such as 'Sup 3 min', 'Std 1 min, and 'Std 3 min'.
Query!
Timepoint [34]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [35]
0
0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Query!
Assessment method [35]
0
0
TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA vital signs parameter results were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 month - \<17 years', the abnormality criteria were '\<3% of normal body weight' in Kilograms (kg) or '\>97% of normal body weight' in kgs. Here, '\<3% of normal' is presented as 'Low' and '\>97% of normal' is presented as 'High'. For the age range '\>=17 years', the abnormality criteria were 'Increase/decrease of \>=10%' body weight in kgs (presented as Inc/Dec A) or 'Increase/decrease of \>=7%' body weight in kgs (presented as Inc/Dec B).
Query!
Timepoint [35]
0
0
During the study (up to approximately 5 years)
Query!
Secondary outcome [36]
0
0
Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
Query!
Assessment method [36]
0
0
The 28-day PGTCS frequency during the relative period was subtracted from the 28-day Combined Baseline PGTCS frequency and the result was divided by 28-day Combined Baseline PGTCS frequency and the result was then multiplied by 100 to get percent change in PGTCS frequency per 28 days from Combined Baseline Period (CB) to the appropriate analysis Period. The CB was defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the study SP0982 or prior to Visit 1 (first dose) if direct enrollers in EP0012.
Query!
Timepoint [36]
0
0
From Combined Baseline until end of Treatment Period (up to approximately 5 years)
Query!
Eligibility
Key inclusion criteria
- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
* Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For all subjects who entered EP0012 directly with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/08/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/03/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
239
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Ep0012 980 - Chatswood
Query!
Recruitment hospital [2]
0
0
Ep0012 985 - Heidelberg
Query!
Recruitment hospital [3]
0
0
Ep0012 986 - Melbourne
Query!
Recruitment hospital [4]
0
0
Ep0012 981 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
- Chatswood
Query!
Recruitment postcode(s) [2]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [4]
0
0
- Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Wisconsin
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Curitiba
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Florianopolis
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Passo Fundo
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Porto Alegre
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Rio de Janeiro
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Sao Paulo
Query!
Country [18]
0
0
Bulgaria
Query!
State/province [18]
0
0
Blagoevgrad
Query!
Country [19]
0
0
Bulgaria
Query!
State/province [19]
0
0
Sofia
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Beijing
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Changchun
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Shanghai
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Ostrava- Poruba
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Prague
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Praha 11
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Zlin
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Bron Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Lille Cedex
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Nancy
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Erlangen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Freiburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Marburg
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Budapest
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Szeged
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Rehovot
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Tel Hashomer
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Torino
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Fukuoka-shi
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Gifu
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Hamamatsu
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Hiroshima
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Kagoshima-city
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Kodaira-city
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Kokubunji-shi
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Niigata-city
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Omura-shi
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Sapporo-city
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Shinjuku-ku
Query!
Country [49]
0
0
Korea, Republic of
Query!
State/province [49]
0
0
Daegu
Query!
Country [50]
0
0
Korea, Republic of
Query!
State/province [50]
0
0
Seoul
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Guadalajara
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Czestochowa
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Gdansk
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Gliwice
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Katowice
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Tyniec Maly
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Warszawa
Query!
Country [58]
0
0
Portugal
Query!
State/province [58]
0
0
Lisboa
Query!
Country [59]
0
0
Romania
Query!
State/province [59]
0
0
Iasi
Query!
Country [60]
0
0
Romania
Query!
State/province [60]
0
0
Timisoara
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
Ekaterinburg
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Kazan
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
Pyatigorsk
Query!
Country [64]
0
0
Russian Federation
Query!
State/province [64]
0
0
Saint Petersburg
Query!
Country [65]
0
0
Russian Federation
Query!
State/province [65]
0
0
Samara
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
St. Petersburg
Query!
Country [67]
0
0
Slovakia
Query!
State/province [67]
0
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Bardejov
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Slovakia
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Hlohovec
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Taichung
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB BIOSCIENCES, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.
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Trial website
https://clinicaltrials.gov/study/NCT02408549
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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UCB Cares
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001 844 599 2273
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
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Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.Vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/49/NCT02408549/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/49/NCT02408549/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02408549