Trial Outcomes & Findings for An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome (NCT NCT02823145)
NCT ID: NCT02823145
Last Updated: 2025-07-14
Results Overview
Treatment-emergent adverse events (TEAE) were defined as any AEs that based on start date information occurs after the first intake of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
From Day 1 to End of OLE Treatment Period - End of Study (EOS) Visit (Month 42)
Results posted on
2025-07-14
Participant Flow
The study started to enroll participants in Jun 2016 and concluded in Jan 2023. Participants who completed 14 weeks treatment in any of the core studies ZX008-1501/ZX008-1502 (NCT02682927), or ZX008-1504 (NCT02926898) Cohort 2, or completed ZX008-1504 Cohort 1 study, and de novo participants were eligible to participate in this study.
The Participant Flow refers to the Safety (SAF) Population.
Participant milestones
| Measure |
Not Treated
Participant (de novo) signed the informed consent form (ICF) but never received any study medication during the study.
|
Any ZX008 Open Label Dose
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|---|
|
Enrollment
STARTED
|
1
|
374
|
|
Enrollment
COMPLETED
|
0
|
374
|
|
Enrollment
NOT COMPLETED
|
1
|
0
|
|
Treatment
STARTED
|
0
|
374
|
|
Treatment
COMPLETED
|
0
|
49
|
|
Treatment
NOT COMPLETED
|
0
|
325
|
Reasons for withdrawal
| Measure |
Not Treated
Participant (de novo) signed the informed consent form (ICF) but never received any study medication during the study.
|
Any ZX008 Open Label Dose
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|---|
|
Enrollment
Other
|
1
|
0
|
|
Treatment
Adverse Event
|
0
|
11
|
|
Treatment
Death
|
0
|
3
|
|
Treatment
Family Decision
|
0
|
1
|
|
Treatment
IP approved and subject moved to commercial drug
|
0
|
1
|
|
Treatment
Lack of Efficacy
|
0
|
48
|
|
Treatment
Non-Compliance With E-Diary
|
0
|
1
|
|
Treatment
Physician Decision
|
0
|
2
|
|
Treatment
Subject has transitioned to study 1900 OLE study
|
0
|
225
|
|
Treatment
Subject needed to take prohibited medication
|
0
|
1
|
|
Treatment
Subject transferred to direct access programme
|
0
|
1
|
|
Treatment
Switching to commercially available drug
|
0
|
11
|
|
Treatment
Transitioned to commercial supply of medication
|
0
|
1
|
|
Treatment
Withdrawal By Caregiver
|
0
|
1
|
|
Treatment
Withdrawal by sponsor due to lack of compliance
|
0
|
1
|
|
Treatment
Withdrawal by Subject
|
0
|
16
|
|
Treatment
Reason unknown
|
0
|
1
|
Baseline Characteristics
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
Baseline characteristics by cohort
| Measure |
Any ZX008 Open Label Dose
n=374 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Age, Continuous
|
10.3 years
STANDARD_DEVIATION 6.12 • n=5 Participants
|
|
Age, Customized
<6 years
|
92 Participants
n=5 Participants
|
|
Age, Customized
6-18 years
|
250 Participants
n=5 Participants
|
|
Age, Customized
>18 years
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
275 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
267 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to End of OLE Treatment Period - End of Study (EOS) Visit (Month 42)Population: Safety (SAF) population included all enrolled participants who received at least one dose of ZX008 during the OLE.
Treatment-emergent adverse events (TEAE) were defined as any AEs that based on start date information occurs after the first intake of study treatment.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=374 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Open-label Extension (OLE) Treatment Period
|
98.1 percentage of participants
|
PRIMARY outcome
Timeframe: From Day 1 to End of OLE Treatment Period - EOS Visit (Month 42)Population: Safety (SAF) population included all enrolled participants who received at least one dose of ZX008 during the OLE.
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. Percentage of participants with TEAEs leading to withdrawal from IMP during OLE Treatment Period were reported.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=374 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the OLE Treatment Period
|
3.5 percentage of participants
|
PRIMARY outcome
Timeframe: From Day 1 to End of OLE Treatment Period - EOS Visit (Month 42)Population: Safety (SAF) population included all enrolled participants who received at least one dose of ZX008 during the OLE.
Serious Adverse event (SAE) was defined as any untoward medical occurrence that at any dose: • results in death, • is life-threatening threatening, • results in initial inpatient hospitalization or prolongation of hospitalization, •results in persistent or significant disability or incapacity, • results in a congenital anomaly/birth defect, • results in any medically significant event that did not meet any of the other 5 SAE criteria, but which was judged by a physician to potentially jeopardize the participant or require medical or surgical intervention to prevent one of the above outcomes listed as an SAE criterion.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=374 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the OLE Treatment Period
|
26.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to End of OLE Treatment Period (EOS Visit - up to Month 42), compared to Baseline (Core)Population: Modified Intent-to-Treat (mITT) population included all enrolled participants who received at least one dose of ZX008 and had at least 1 month of valid seizure data during the OLE.
Baseline (Core) was defined as Baseline prior to double-blind treatment in the core studies (ZX008-1501/ZX008-1502, and ZX008-1504 Cohort 2). Participants in 1504- Cohort 1 and de novo participants (who entered 1503 without having been in any of the core studies) did not have a Baseline (Core), and were not included in the analysis of this outcome measure. The total number of convulsive seizures from Day 1 to EOS was divided by the total number of days from Day 1 to EOS with nonmissing diary data and the result was then multiplied by 28 to get a 28-day convulsive seizure frequency (CSF). The change from Baseline for any individual participant was calculated by subtracting the Baseline (Core) from the post-baseline value. Monthly (28 day) CSF was based on electronic diary data obtained for each participant.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=324 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Change From Baseline (Core) in Convulsive Seizure Frequency Per 28 Days From Day 1 to End of Study (EOS) Visit (Month 42) in the OLE Treatment Period
|
-6.67 seizure frequency per 28 days
Interval -1757.8 to 751.3
|
SECONDARY outcome
Timeframe: From Month 2 to End of OLE Treatment Period (EOS Visit - up to Month 42), compared to Baseline (Core)Population: mITT population included all enrolled participants who received at least one dose of ZX008 and had at least 1 month of valid seizure data during the OLE. Here, number of participants analyzed included those participants who were evaluable for the assessment.
Baseline (Core) was defined as Baseline prior to double-blind treatment in the core studies. Participants in 1504-Cohort 1 and de novo participants did not have a Baseline (Core), and were not included in the analysis of this outcome measure. The total number of convulsive seizures from Month 2 to EOS was divided by the total number of days from Month 2 to EOS with nonmissing diary data and the result was then multiplied by 28 to get a 28-day CSF. The change from Baseline for any individual participant was calculated by subtracting the Baseline (Core) from the post-baseline value. Monthly (28 day) CSF was based on electronic diary data obtained for each participant.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=323 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Change From Baseline (Core) in Convulsive Seizure Frequency Per 28 Days From Month 2 to EOS (Month 42) in the OLE Treatment Period
|
-7.04 seizure frequency per 28 days
Interval -1986.9 to 816.4
|
SECONDARY outcome
Timeframe: At Month 1, Month 2, Month 3, Month 4-6, Month 7-9, Month 10-12, Month 13-15, Month 16-18, Month 19-21, Month 22-24, Month 25-27, Month 28-30, Month 31-33, and Month 34-36Population: mITT population included all enrolled participants who received at least one dose of ZX008 and had at least 1 month of valid seizure data during the OLE. Here, number analyzed signifies participants who were evaluable at specified time points.
Monthly (28 day) CSF was based on electronic diary data obtained for each participant. The total number of convulsive seizures in the ith interval (CSF in OLE, where, i=1, 2, 3, … , 14 ) was divided by the total number of days in the ith interval with nonmissing diary data and the result was then multiplied by 28 to get a 28-day CSF of OLE.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=324 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 1
|
6.53 seizure frequency per 28 days
Interval 0.0 to 4876.9
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 2
|
4.67 seizure frequency per 28 days
Interval 0.0 to 3392.7
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 3
|
4.67 seizure frequency per 28 days
Interval 0.0 to 2593.7
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 4-6
|
4.36 seizure frequency per 28 days
Interval 0.0 to 1725.5
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 7-9
|
3.82 seizure frequency per 28 days
Interval 0.0 to 310.8
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 10-12
|
4.04 seizure frequency per 28 days
Interval 0.0 to 362.4
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 13-15
|
3.11 seizure frequency per 28 days
Interval 0.0 to 215.0
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 16-18
|
3.42 seizure frequency per 28 days
Interval 0.0 to 243.3
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 19-21
|
3.42 seizure frequency per 28 days
Interval 0.0 to 372.4
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 22-24
|
2.80 seizure frequency per 28 days
Interval 0.0 to 489.5
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 25-27
|
2.80 seizure frequency per 28 days
Interval 0.0 to 747.3
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 28-30
|
2.80 seizure frequency per 28 days
Interval 0.0 to 242.5
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 31-33
|
3.21 seizure frequency per 28 days
Interval 0.0 to 224.0
|
|
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
Month 34-36
|
2.74 seizure frequency per 28 days
Interval 0.0 to 56.0
|
SECONDARY outcome
Timeframe: From Day 1 to End of OLE Treatment Period - End of Study (EOS) Visit (Month 42)Population: mITT population included all enrolled participants who received at least one dose of ZX008 and had at least 1 month of valid seizure data during the OLE. Here, number analyzed represents the number of participants categorized by mean daily dose.
Convulsive seizure frequency over time, reported as per 28 days was analyzed by the actual dose administered. Participants were grouped into low (0.2 to \<0.4 mg/kg), medium (0.4 to \<0.6 mg/kg), and high dose (\>0.6 mg/kg) groups depending on their mean daily doses of ZX008 during the OLE Treatment period. For each participant, the seizure frequency per 28 days was calculated as the number of seizures recorded during the period, divided by the number of days in the period and multiplied by 28. The convulsive seizure frequency was calculated from all available data collected.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=324 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Convulsive Seizure Frequency (CSF) by Mean Daily Dose During the Overall OLE Treatment Period
ZX008 Low Dose (0 - <0.4 mg/kg/day)
|
3.94 seizure frequency per 28 days
Interval 0.0 to 2215.3
|
|
Convulsive Seizure Frequency (CSF) by Mean Daily Dose During the Overall OLE Treatment Period
ZX008 Medium Dose (0.4 - <0.6 mg/kg/day)
|
4.80 seizure frequency per 28 days
Interval 0.0 to 113.6
|
|
Convulsive Seizure Frequency (CSF) by Mean Daily Dose During the Overall OLE Treatment Period
ZX008 High Dose (>=0.6 mg/kg/day)
|
6.00 seizure frequency per 28 days
Interval 0.1 to 942.8
|
SECONDARY outcome
Timeframe: At Month 1, 2, 3, 4 , 5, and 6 of OLE Treatment PeriodPopulation: mITT population included all enrolled participants who received at least one dose of ZX008 and had at least 1 month of valid seizure data during the OLE.
Participants in the study were required to be on stable background therapy for the first 6 months of treatment, after which background AEDs could be reduced or withdrawn so long as one background AED remained. The percentage of participants who had changes in dose or type of concomitant AED medications during the first, second, third, fourth, fifth, and sixth months were analyzed and reported.
Outcome measures
| Measure |
Any ZX008 Open Label Dose
n=324 Participants
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 1
|
5.2 percentage of participants
|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 2
|
7.1 percentage of participants
|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 3
|
7.4 percentage of participants
|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 4
|
8.3 percentage of participants
|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 5
|
6.8 percentage of participants
|
|
Percentage of Participants With Changes in Antiepileptic Drug (AED) Medications During First 6 Months of OLE Treatment Period
OLE Month 6
|
9.6 percentage of participants
|
Adverse Events
Any ZX008 Open Label Dose
Serious events: 99 serious events
Other events: 342 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Any ZX008 Open Label Dose
n=374 participants at risk
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Colitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Constipation
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Abasia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Fatigue
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Hypothermia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Impaired healing
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Sudden unexplained death in epilepsy
|
0.80%
3/374 • Number of events 3 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Atypical pneumonia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Bronchitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Bronchitis viral
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Cellulitis
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Enterovirus infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Epididymitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Gastroenteritis
|
0.80%
3/374 • Number of events 3 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Helicobacter infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Infectious mononucleosis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Influenza
|
1.9%
7/374 • Number of events 8 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.80%
3/374 • Number of events 3 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Lung infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Otitis media acute
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Pharyngitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Pneumonia
|
3.2%
12/374 • Number of events 15 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Postoperative wound infection
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Rhinovirus infection
|
0.27%
1/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Sepsis
|
0.80%
3/374 • Number of events 4 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Tonsillitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Varicella
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Viral infection
|
1.3%
5/374 • Number of events 5 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Viral pharyngitis
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Investigations
Blood glucose decreased
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Investigations
Heart rate decreased
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
2/374 • Number of events 3 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
1/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Musculoskeletal and connective tissue disorders
Aneurysmal bone cyst
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Change in seizure presentation
|
1.3%
5/374 • Number of events 6 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Dystonia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Encephalopathy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Epilepsy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Febrile convulsion
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.53%
2/374 • Number of events 4 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Hyperkinesia
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Hypotonia
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Lethargy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Movement disorder
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Myoclonus
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Seizure
|
5.6%
21/374 • Number of events 26 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Seizure cluster
|
1.6%
6/374 • Number of events 9 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Status epilepticus
|
4.0%
15/374 • Number of events 18 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Acute psychosis
|
0.27%
1/374 • Number of events 4 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Agitation
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Apathy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Insomnia
|
0.80%
3/374 • Number of events 3 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Tic
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.53%
2/374 • Number of events 2 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Surgical and medical procedures
Labial frenectomy
|
0.27%
1/374 • Number of events 1 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
Other adverse events
| Measure |
Any ZX008 Open Label Dose
n=374 participants at risk
Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, twice a day (bid), in equally divided doses with food for 1 month. After 1 month, investigator might have adjusted the dose of each participant based on effectiveness and tolerability. Participants who were not receiving concomitant stiripentol, dose changes should be made in increments of 0.2 mg/kg/day, to a maximum of 0.8 mg/kg/day but not to exceed total dose of 30 mg/day for 42 months of OLE Period. Participants who were receiving concomitant stiripentol, the first dose change was 0.4 mg/kg/day and the final dose change was to 0.5 mg/kg/day, but not to exceed 20 mg/day for 42 months of OLE Period.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.1%
23/374 • Number of events 34 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.5%
73/374 • Number of events 102 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
39/374 • Number of events 50 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Fatigue
|
9.1%
34/374 • Number of events 49 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
General disorders
Pyrexia
|
29.9%
112/374 • Number of events 229 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Ear infection
|
10.4%
39/374 • Number of events 56 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Gastroenteritis
|
8.6%
32/374 • Number of events 34 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
20/374 • Number of events 21 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Influenza
|
12.0%
45/374 • Number of events 50 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Nasopharyngitis
|
27.8%
104/374 • Number of events 224 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Rhinitis
|
8.6%
32/374 • Number of events 62 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.4%
65/374 • Number of events 117 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Viral infection
|
7.2%
27/374 • Number of events 40 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.1%
19/374 • Number of events 36 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
25/374 • Number of events 26 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Investigations
Blood glucose decreased
|
23.5%
88/374 • Number of events 115 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Investigations
Echocardiogram abnormal
|
17.9%
67/374 • Number of events 82 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Investigations
Weight decreased
|
8.3%
31/374 • Number of events 33 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
100/374 • Number of events 112 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.6%
32/374 • Number of events 35 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Seizure
|
12.3%
46/374 • Number of events 60 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Somnolence
|
9.4%
35/374 • Number of events 38 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Nervous system disorders
Tremor
|
5.6%
21/374 • Number of events 24 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Abnormal behaviour
|
5.9%
22/374 • Number of events 28 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Psychiatric disorders
Irritability
|
5.1%
19/374 • Number of events 23 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
34/374 • Number of events 55 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
20/374 • Number of events 20 • From Day 1 up to 42 months
A TEAE was defined as any AE that based on start date information occurs after the first intake of study treatment. The Safety (SAF) population was the set of all enrolled subjects who received at least one dose of ZX008 during the OLE. As pre-specified in the SAP, safety analyses were performed on the SAF Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60