Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy (NCT NCT04378075)
NCT ID: NCT04378075
Last Updated: 2026-03-31
Results Overview
The 28-day motor seizure frequency in the double-blind period was calculated as the (number of motor seizures)/ (the number of valid days where motor seizure count information is present) \* 28 within the double-blind period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
68 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2026-03-31
Participant Flow
A total of 82 participants were screened, of which 14 were not randomized due to screen failure.
Participant milestones
| Measure |
Double-blind Period: Vatiquinone
Participants received vatiquinone 15 milligrams (mg)/kilogram (kg) if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, 3 times per day (TID) for up to 24 weeks during the double-blind period.
|
Double-blind Period: Placebo
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Long-term Extension: Vatiquinone/Vatiquinone
Participants who received vatiquinone for 24 weeks in the double-blind period continued to receive vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
Long-term Extension: Placebo/Vatiquinone
Participants who received placebo for 24 weeks in the double-blind period, received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
|---|---|---|---|---|
|
Double-blind (24 Weeks)
STARTED
|
34
|
34
|
0
|
0
|
|
Double-blind (24 Weeks)
Received at Least 1 Dose of Study Drug
|
34
|
34
|
0
|
0
|
|
Double-blind (24 Weeks)
COMPLETED
|
28
|
29
|
0
|
0
|
|
Double-blind (24 Weeks)
NOT COMPLETED
|
6
|
5
|
0
|
0
|
|
Long-term Extension (48 Weeks)
STARTED
|
0
|
0
|
28
|
29
|
|
Long-term Extension (48 Weeks)
COMPLETED
|
0
|
0
|
16
|
18
|
|
Long-term Extension (48 Weeks)
NOT COMPLETED
|
0
|
0
|
12
|
11
|
Reasons for withdrawal
| Measure |
Double-blind Period: Vatiquinone
Participants received vatiquinone 15 milligrams (mg)/kilogram (kg) if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, 3 times per day (TID) for up to 24 weeks during the double-blind period.
|
Double-blind Period: Placebo
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Long-term Extension: Vatiquinone/Vatiquinone
Participants who received vatiquinone for 24 weeks in the double-blind period continued to receive vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
Long-term Extension: Placebo/Vatiquinone
Participants who received placebo for 24 weeks in the double-blind period, received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
|---|---|---|---|---|
|
Double-blind (24 Weeks)
Adverse Event
|
2
|
2
|
0
|
0
|
|
Double-blind (24 Weeks)
Death
|
3
|
0
|
0
|
0
|
|
Double-blind (24 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Double-blind (24 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Double-blind (24 Weeks)
Other than specified
|
0
|
2
|
0
|
0
|
|
Long-term Extension (48 Weeks)
Death
|
0
|
0
|
2
|
2
|
|
Long-term Extension (48 Weeks)
Other than specified
|
0
|
0
|
9
|
7
|
|
Long-term Extension (48 Weeks)
Sponsor's decision
|
0
|
0
|
1
|
1
|
|
Long-term Extension (48 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
Baseline characteristics by cohort
| Measure |
Double-blind Period: Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 24 weeks during the double-blind period.
|
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.7 years
STANDARD_DEVIATION 5.34 • n=4 Participants
|
6.6 years
STANDARD_DEVIATION 4.84 • n=28 Participants
|
7.6 years
STANDARD_DEVIATION 5.17 • n=10 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=4 Participants
|
20 Participants
n=28 Participants
|
34 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=4 Participants
|
14 Participants
n=28 Participants
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=4 Participants
|
30 Participants
n=28 Participants
|
56 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
9 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=4 Participants
|
9 Participants
n=28 Participants
|
12 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
1 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
24 Participants
n=4 Participants
|
20 Participants
n=28 Participants
|
44 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
5 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
|
Number of Observable Motor Seizures per 28 Days
|
112.5 motor seizures/28 days
n=4 Participants
|
237.0 motor seizures/28 days
n=28 Participants
|
164.0 motor seizures/28 days
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The 28-day motor seizure frequency in the double-blind period was calculated as the (number of motor seizures)/ (the number of valid days where motor seizure count information is present) \* 28 within the double-blind period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in the Number of Observable Motor Seizures Per 28 Days During the Double-blind Period
|
-0.33 percent change
95% Confidence Interval -28.97 • Interval -28.97 to 17.06
|
-12.74 percent change
95% Confidence Interval -28.67 • Interval -28.67 to 9.42
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The disease-related hospitalization days per 28 days in the double-blind period was calculated as the (number of disease-related hospitalizations)/(the number of days within the double-blind period) \* 28. The baseline hospitalization used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Number of Disease-Related Hospitalization Days Per 28 Days in Double-Blind Period
|
0 days
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 days
95% Confidence Interval 0 • Interval 0.0 to 1.16
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The disease-related hospitalization days per 28 days in the overall period was calculated as the (number of disease-related hospitalizations)/(the number of days within the overall treatment period) \* 28. The baseline hospitalization used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 72 in Number of Disease-Related Hospitalization Days Per 28 Days in Overall Period
|
0.166 days
Interval 0.0 to 0.515
|
0.363 days
Interval 0.0 to 1.304
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The status epilepticus per 28 Days in the double-blind period was calculated as the (number of status epilepticus incidences)/(the number of days in the double-blind period) \* 28. The baseline status epilepticus incidences used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Occurrence/Recurrence of Status Epilepticus Per 28 Days in Double-blind Period
|
-0.026 status epilepticus per 28 days
Standard Deviation 1.1083 • Interval 1.1083 to
|
0.039 status epilepticus per 28 days
Standard Deviation 0.9564 • Interval 0.9564 to
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The status epilepticus per 28 Days in the overall period was calculated as the (number of status epilepticus incidences)/(the number of days in the overall period) \* 28. The baseline status epilepticus incidences used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 72 in Occurrence/Recurrence of Status Epilepticus Per 28 Days in Overall Period
|
-0.102 status epilepticus per 28 days
Standard Deviation 1.0094
|
0.036 status epilepticus per 28 days
Standard Deviation 0.6444
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
In-patient hospitalization per 28 days in the double-blind period was calculated as the (number of in-patient hospitalization)/(the number of days in the double-blind period) \* 28. The baseline in-patient hospitalization used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with in-patient hospitalizations for either seizure or epilepticus per 28 days in double-blind period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Disease-Related In-Patient Hospitalizations in Double-Blind Period
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
In-patient hospitalization per 28 days in the overall period was calculated as the (number of in-patient hospitalization)/(the number of days in the overall period) \* 28. The baseline in-patient hospitalization used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with in-patient hospitalizations for either seizure or epilepticus per 28 days in overall period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Disease-Related In-Patient Hospitalizations in Overall Period
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Disease-related emergency room visits per 28 days in the double-blind period was calculated as the (number of disease-related emergency room visits)/(the number of days in the double-blind period) \* 28. The baseline disease-related emergency room visits used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with disease-related emergency room visits for either seizure or epilepticus per 28 days in double-blind period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Disease-Related Emergency Room Visits in Double-Blind Period
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Disease-related emergency room visits per 28 days in the overall period was calculated as the (number of disease-related emergency room visits)/(the number of days in the overall period) \* 28. The baseline disease-related emergency room visits used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with disease-related emergency room visits for either seizure or epilepticus per 28 days in overall period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Disease-Related Emergency Room Visits in Overall Period
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
In-patient hospitalization per 28 days in the double-blind period was calculated as the (number of in-patient hospitalization)/(the number of days in the double-blind period) \* 28. The baseline in-patient hospitalization used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with number of in-patient hospitalizations for either seizure or epilepticus per 28 days in double-blind period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Disease-Related In-Patient Hospitalizations in Double-Blind Period
0 Hospitalization
|
32 Participants
|
28 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Double-Blind Period
1 Hospitalization
|
1 Participants
|
4 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Double-Blind Period
2 Hospitalizations
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Double-Blind Period
7 Hospitalizations
|
1 Participants
|
0 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Double-Blind Period
10 Hospitalizations
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
In-patient hospitalization per 28 days in the overall period was calculated as the (number of in-patient hospitalization)/(the number of days in the overall period) \* 28. The baseline in-patient hospitalization used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with number in-patient hospitalizations for either seizure or epilepticus per 28 days in overall period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
0 Hospitalization
|
31 Participants
|
23 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
1 Hospitalization
|
1 Participants
|
7 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
2 Hospitalizations
|
1 Participants
|
0 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
5 Hospitalizations
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
6 Hospitalizations
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
7 Hospitalizations
|
1 Participants
|
0 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
8 Hospitalizations
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related In-Patient Hospitalizations in Overall Period
10 Hospitalizations
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Disease-related emergency room visits per 28 days in the double-blind period was calculated as the (number of disease-related emergency room visits)/(the number of days in the double-blind period) \* 28. The baseline disease-related emergency room visits used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with number of emergency room visits for either seizure or epilepticus per 28 days in double-blind period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Disease-Related Emergency Room Visits in Double-Blind Period
0 Visit
|
30 Participants
|
25 Participants
|
|
Number of Disease-Related Emergency Room Visits in Double-Blind Period
1 Visit
|
4 Participants
|
7 Participants
|
|
Number of Disease-Related Emergency Room Visits in Double-Blind Period
2 Visits
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related Emergency Room Visits in Double-Blind Period
10 Visits
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Disease-related emergency room visits per 28 days in the overall period was calculated as the (number of disease-related emergency room visits)/(the number of days in the overall period) \* 28. The baseline disease-related emergency room visits used the 28 days observations immediately prior to treatment start date for this calculation. Number of participants with number of emergency room visits for either seizure or epilepticus per 28 days in overall period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Disease-Related Emergency Room Visits in Overall Period
8 Visits
|
0 Participants
|
1 Participants
|
|
Number of Disease-Related Emergency Room Visits in Overall Period
0 Visit
|
29 Participants
|
20 Participants
|
|
Number of Disease-Related Emergency Room Visits in Overall Period
1 Visit
|
4 Participants
|
8 Participants
|
|
Number of Disease-Related Emergency Room Visits in Overall Period
2 Visits
|
1 Participants
|
2 Participants
|
|
Number of Disease-Related Emergency Room Visits in Overall Period
6 Visits
|
0 Participants
|
2 Participants
|
|
Number of Disease-Related Emergency Room Visits in Overall Period
10 Visits
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
The total seizure frequency per 28 days in the double-blind period was calculated as the (number of total seizures)/(the number of valid days where total seizure count information is present) \* 28 within the double-blind period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Total Seizure Frequency Per 28 Days in Double-Blind Period
|
-5.73 percent change
95% Confidence Interval -31.59 • Interval -31.59 to 7.79
|
-14.27 percent change
95% Confidence Interval -34.52 • Interval -34.52 to 21.85
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Overall period was defined as the period from the first dosing date of investigational product (IP) during double-blind period to the end of study (double-blind + open-label period). The 28 day total seizure frequency in the overall period was calculated as the (number of total seizures)/(the number of valid days where total seizure count information is present) \* 28 within the overall period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 72 in Total Seizure Frequency Per 28 Days in Overall Period
|
-7.52 percent change
Interval -35.46 to 17.0
|
-17.03 percent change
Interval -42.38 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Number of participants taking rescue medications for epilepsy in double-blind period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants Taking Rescue Medications in the Double-blind Period
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Number of participants taking rescue medications for epilepsy in overall period are reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants Taking Rescue Medications in the Overall Period
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
The CarerQol-7D consists of 5 negative and 2 positive dimensions of providing informal care. The negative dimensions are relational problems, mental health problems, problems combining daily activities with care, financial problems and physical health problems because of providing informal care. The 2 positive dimensions are fulfilment from caregiving and support with lending care. For each dimension, there are 3 possible responses: no, some and a lot. Utility tariffs for CarerQol have been developed to calculate a weighted sum score of CarerQol-7D from the responses on the 7 dimensions, ranging from 0 (worst imaginable caregiving situation) to 100 (best imaginable caregiving situation), for which discrete choice experiments were used. Higher sum scores reflect better care-related quality of life.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=2 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=5 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Health-Related Quality of Life as Measured by the Care-Related Quality of Life of Informal Caregivers (CarerQoL-7D) Questionnaire Score in Double-blind Period
|
-5.25 units on a scale
Standard Deviation 10.112 • Interval 10.112 to
|
-10.38 units on a scale
Standard Deviation 18.207 • Interval 18.207 to
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
The CarerQol-7D consists of 5 negative and 2 positive dimensions of providing informal care. The negative dimensions are relational problems, mental health problems, problems combining daily activities with care, financial problems and physical health problems because of providing informal care. The 2 positive dimensions are fulfilment from caregiving and support with lending care. For each dimension, there are 3 possible responses: no, some and a lot. Utility tariffs for CarerQol have been developed to calculate a weighted sum score of CarerQol-7D from the responses on the 7 dimensions, ranging from 0 (worst imaginable caregiving situation) to 100 (best imaginable caregiving situation), for which discrete choice experiments were used. Higher sum scores reflect better care-related quality of life.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=10 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=12 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Change From Baseline to Week 72 in Health-Related Quality of Life as Measured by the CarerQoL-7D Questionnaire Score in Overall Period
|
-3.14 units on a scale
Standard Deviation 13.675
|
-0.95 units on a scale
Standard Deviation 14.235
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Seizure clusters were defined by "too many to count" entries in the seizure diaries. The motor seizure clusters per 28 days in the double-blind period was calculated as the (number of motor seizure clusters)/(the number of valid days where motor seizure clusters count information was present) \* 28 within the double-blind period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Motor Seizure Clusters in Double-Blind Period
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Seizure clusters were defined by "too many to count" entries in the seizure diaries. The motor seizure clusters per 28 days in the overall period was calculated as the (number of motor seizure clusters)/(the number of valid days where motor seizure clusters count information was present) \* 28 within the overall period. The baseline of the seizure frequency used the 28 days observations immediately prior to treatment start date for this calculation.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Motor Seizure Clusters in Overall Period
|
26 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Number of participants whose motor seizure frequency reduction per 28 days was more than the specified percentage compared to baseline were reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Motor Seizures Per 28 Days During the Double-blind Period
< -60% to -100%
|
4 Participants
|
3 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Motor Seizures Per 28 Days During the Double-blind Period
>30%
|
9 Participants
|
7 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Motor Seizures Per 28 Days During the Double-blind Period
30% to -30%
|
14 Participants
|
17 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Motor Seizures Per 28 Days During the Double-blind Period
< -30% to -60%
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population included all randomized participants who received at least 1 dose of treatment.
Number of participants whose total seizure frequency reduction per 28 days was more than the specified percentage compared to baseline were reported.
Outcome measures
| Measure |
Double-blind Period: Placebo
n=34 Participants
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
Overall Period: Vatiquinone/Vatiquinone
n=34 Participants
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 72 weeks.
|
|---|---|---|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Total Seizures Per 28 Days During the Double-blind Period
>30%
|
7 Participants
|
7 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Total Seizures Per 28 Days During the Double-blind Period
30% to -30%
|
15 Participants
|
13 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Total Seizures Per 28 Days During the Double-blind Period
< -30% to -60%
|
9 Participants
|
10 Participants
|
|
Number of Participants With >30%, 30% to -30%, < -30% to -60%, < -60% to -100% Reduction in Total Seizures Per 28 Days During the Double-blind Period
< -60% to -100%
|
3 Participants
|
4 Participants
|
Adverse Events
Double-blind Period: Vatiquinone
Serious events: 18 serious events
Other events: 26 other events
Deaths: 3 deaths
Double-blind Period: Placebo
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
On-Vatiquinone Period: Vatiquinone/Vatiquinone
Serious events: 26 serious events
Other events: 30 other events
Deaths: 5 deaths
On-Vatiquinone Period: Placebo/Vatiquinone
Serious events: 16 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Double-blind Period: Vatiquinone
n=34 participants at risk
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 24 weeks during the double-blind period.
|
Double-blind Period: Placebo
n=34 participants at risk
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
On-Vatiquinone Period: Vatiquinone/Vatiquinone
n=34 participants at risk
Participants who received vatiquinone for 24 weeks in the double-blind period continued to receive vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
On-Vatiquinone Period: Placebo/Vatiquinone
n=29 participants at risk
Participants who received placebo for 24 weeks in the double-blind period, received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
General disorders
Death
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
General disorders
Hypothermia
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
COVID-19
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
14.7%
5/34 • Number of events 5 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
13.8%
4/29 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia viral
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Rhinovirus infection
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Investigations
Urine output decreased
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Seizure
|
11.8%
4/34 • Number of events 8 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
20.6%
7/34 • Number of events 15 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Status epilepticus
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
General disorders
Disease progression
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Metabolism and nutrition disorders
Mitochondrial cytopathy
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Change in seizure presentation
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Psychiatric disorders
Inappropriate affect
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
Other adverse events
| Measure |
Double-blind Period: Vatiquinone
n=34 participants at risk
Participants received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for up to 24 weeks during the double-blind period.
|
Double-blind Period: Placebo
n=34 participants at risk
Participants received vatiquinone-matched placebo, administered orally, TID for up to 24 weeks during the double-blind period.
|
On-Vatiquinone Period: Vatiquinone/Vatiquinone
n=34 participants at risk
Participants who received vatiquinone for 24 weeks in the double-blind period continued to receive vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
On-Vatiquinone Period: Placebo/Vatiquinone
n=29 participants at risk
Participants who received placebo for 24 weeks in the double-blind period, received vatiquinone 15 mg/kg if body weight \<13 kg, and 200 mg if body weight ≥13 kg, administered orally, TID for 48 weeks during the long-term extension period.
|
|---|---|---|---|---|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Ear infection
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
11.8%
4/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
7/34 • Number of events 7 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
29.4%
10/34 • Number of events 14 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 5 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
General disorders
Pyrexia
|
11.8%
4/34 • Number of events 6 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
26.5%
9/34 • Number of events 12 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
COVID-19
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
10.3%
3/29 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 5 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
11.8%
4/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
14.7%
5/34 • Number of events 10 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
24.1%
7/29 • Number of events 10 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Urinary tract infection
|
8.8%
3/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
11.8%
4/34 • Number of events 11 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 6 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
11.8%
4/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Change in seizure presentation
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
6.9%
2/29 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Seizure
|
11.8%
4/34 • Number of events 4 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
23.5%
8/34 • Number of events 10 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Nervous system disorders
Somnolence
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Psychiatric disorders
Agitation
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 3 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
3.4%
1/29 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
5.9%
2/34 • Number of events 2 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.9%
1/34 • Number of events 1 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/34 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
8.8%
3/34 • Number of events 5 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
0.00%
0/29 • Baseline up to Week 77
Double-blind phase: Safety analysis set included all randomized participants who received at least 1 dose of treatment. On-Vatiquinone period: On-Vatiquinone safety analysis set included all randomized participants who received at least 1 dose of Vatiquinone anytime during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the sponsor for review. The sponsor may consult with the PI to require changes to the communication or extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER