Trial Outcomes & Findings for Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS) (NCT NCT00950248)
NCT ID: NCT00950248
Last Updated: 2019-03-19
Results Overview
The AUCs of the CombiWISE scores during the 2-year treatment period was analyzed using an Analysis of Covariance (ANCOVA) model with the AUC of the pre-treatment CombiWISE scores, Baseline (Month 0) CombiWISE score and Baseline age as covariates. CombiWISE is a composite scale derived from Expanded Disability Status Scale (EDSS) , Scripps Neurological Disability Scale (SNRS), times 25 foot walk (25FW), and non-dominant hand of 9 hole peg test (9HPT) with a minimum value of 0 (no disability) and maximum value of 100 (maximum disability). The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18, and 24). Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
1-year pre-treatment baseline vs 2-year treatment period
Results posted on
2019-03-19
Participant Flow
Between November 1, 2009 and July 23, 2015, 85 patients were assessed for eligibility and enrolled into the IPPoMS trial at National Institutes of Health, Bethesda, MD
Participant milestones
| Measure |
Untreated
Patients in their first year baseline prior to study drug phase
|
Idebenone
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|---|
|
Year 1: Baseline
STARTED
|
85
|
0
|
0
|
|
Year 1: Baseline
COMPLETED
|
77
|
0
|
0
|
|
Year 1: Baseline
NOT COMPLETED
|
8
|
0
|
0
|
|
Year 2&3 Treatment Randomization
STARTED
|
0
|
39
|
38
|
|
Year 2&3 Treatment Randomization
COMPLETED
|
0
|
33
|
33
|
|
Year 2&3 Treatment Randomization
NOT COMPLETED
|
0
|
6
|
5
|
Reasons for withdrawal
| Measure |
Untreated
Patients in their first year baseline prior to study drug phase
|
Idebenone
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|---|
|
Year 1: Baseline
Withdrawal by Subject
|
6
|
0
|
0
|
|
Year 1: Baseline
worsening of symptoms
|
2
|
0
|
0
|
|
Year 2&3 Treatment Randomization
worsening of symptoms
|
0
|
2
|
4
|
|
Year 2&3 Treatment Randomization
Withdrawal by Subject
|
0
|
3
|
0
|
|
Year 2&3 Treatment Randomization
Death
|
0
|
0
|
1
|
|
Year 2&3 Treatment Randomization
MRI contraindication
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)
Baseline characteristics by cohort
| Measure |
Idebenone
n=39 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=38 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age at Disease onset
|
43.2 years
n=5 Participants
|
42.6 years
n=7 Participants
|
42.9 years
n=5 Participants
|
|
Time since disease onset at baseline
|
13.6 years
n=5 Participants
|
11.9 years
n=7 Participants
|
12.7 years
n=5 Participants
|
|
Body Mass Index
|
25.7 kg/m2
n=5 Participants
|
25.8 kg/m2
n=7 Participants
|
25.8 kg/m2
n=5 Participants
|
|
History of Mononucleosis
Positive
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
History of Mononucleosis
Negative
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
History of Mononucleosis
Unknown
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Northern European Ancestry
Positive
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Northern European Ancestry
Negative
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Northern European Ancestry
Unknown
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Family History of MS
Positive
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Family History of MS
Negative
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Family History of MS
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of Smoking
Positive
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
History of Smoking
Negative
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of Smoking
Unknown
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The primary outcome was assessed in Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.
The AUCs of the CombiWISE scores during the 2-year treatment period was analyzed using an Analysis of Covariance (ANCOVA) model with the AUC of the pre-treatment CombiWISE scores, Baseline (Month 0) CombiWISE score and Baseline age as covariates. CombiWISE is a composite scale derived from Expanded Disability Status Scale (EDSS) , Scripps Neurological Disability Scale (SNRS), times 25 foot walk (25FW), and non-dominant hand of 9 hole peg test (9HPT) with a minimum value of 0 (no disability) and maximum value of 100 (maximum disability). The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18, and 24). Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases.
Outcome measures
| Measure |
Idebenone
n=38 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=35 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in the Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE) From Baseline to Treatment Phase
|
-0.13 units on a scale per year
Standard Deviation 2.17
|
-1.04 units on a scale per year
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The primary outcome was assessed in Intention-to-treat population. Due to technical error in MRI images processing 2 out of 38 idebenone patients were excluded from the analysis.
The AUCs of the Ventricular volume scores (individualized rates of enlargement of segmented volume of lateral and 3rd ventricles) during the baseline and the 2-year treatment period were assessed using an ANCOVA model with the AUC of the pre-treatment Volumetric score, Baseline (Month 0) Volumetric score, and group as covariates. The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18 and 24). Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases.
Outcome measures
| Measure |
Idebenone
n=36 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=35 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in the AUC of Individualized Rates of Enlargement of Ventricular Volume From Baseline to Treatment Phase
|
-244 ml per year
Standard Deviation 1094.9
|
35.4382 ml per year
Standard Deviation 1091.1
|
SECONDARY outcome
Timeframe: 2-year treatment periodPopulation: The outcome was assessed in the Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.
Categorical time-to-event endpoints (EDSS-plus) were analyzed using Cox Proportional hazards models, with treatment group as a covariate. The EDSS-plus event was defined as disability progression on at least 1 of 3 components \[EDSS, 25FW, and/or non-dominant hand 9HPT\]) confirmed 6 months apart and with a ≥ 20% minimum threshold change for 25FW and non-dominant hand 9HPT). The patients who did not have an event during the study were censored at the time of the last assessment of EDSS-plus. The number of months from the date of first dose to date of event or censoring were used as endpoint. The measure is time to disease progression and unit of this measure is months.
Outcome measures
| Measure |
Idebenone
n=38 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=35 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Disability Progression Measured by EDSS-plus
|
23.1 months
Interval 12.8 to
the upper limit of the 95% confidence interval cannot be estimated due to insufficient number of participants with events
|
23.7 months
Interval 19.8 to
the upper limit of the 95% confidence interval cannot be estimated due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Lower extremity disability was measured by an average of two trials of timed 25 foot walk assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0. The maximum time assigned for a trial is 180s. Patients unable to complete the 25 foot trial within this time limit are coded as "179.9"
Outcome measures
| Measure |
Idebenone
n=33 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=33 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in Slopes of 25FW Time From Baseline to Treatment Phase
|
0.02451 seconds per year
Standard Error 0.01668
|
-0.01015 seconds per year
Standard Error 0.01889
|
SECONDARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
Upper extremity/fine motor movements disability was measured as an average of left and right hand time, with each hand assessed as an average of two trials with upper limit of 5 (300s) per trial. Patients unable to complete the task within this time are coded as "777" The outcome was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Outcome measures
| Measure |
Idebenone
n=33 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=33 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in Slopes of 9HPT Time From Baseline to Treatment Phase
|
0.001693 seconds per year
Standard Error 0.000843
|
-0.0003 seconds per year
Standard Error 0.000955
|
SECONDARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
SNRS scale combines various elements of a neurological exam into a single number. The scale ranges from 100 to 0, where 100 marks no disability and 0 marks maximum disability. SNRS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Outcome measures
| Measure |
Idebenone
n=33 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=33 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in Slopes of SNRS From Baseline to Treatment Phase on
|
1.5728 units on a scale per year
Standard Error 0.9743
|
0.2315 units on a scale per year
Standard Error 0.9702
|
SECONDARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year treatment periodPopulation: The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.
EDSS scale combines various elements of neurological exam. EDSS is a discrete scale ranging from 0 to 10 with 0.5 point increments. EDSS of 0 means no neurological disability, while EDSS of 10 marks death due to MS. EDSS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase.The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.
Outcome measures
| Measure |
Idebenone
n=33 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=33 Participants
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|
|
Change in Slopes of EDSS From Baseline to Treatment Phase
|
1.6148 units on a scale per year
Standard Error 3.762
|
-3.7879 units on a scale per year
Standard Error 3.7214
|
Adverse Events
Untreated
Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths
Idebenone
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Untreated
n=85 participants at risk
Patients in their first year baseline prior to study drug phase
|
Idebenone
n=39 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=38 participants at risk
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.5%
3/85 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Chest pain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Dizziness
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Asthenia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Lyme disease
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Catheter management
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Condition aggravated
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Cholecystectomy
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Loss of consciousness
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Pain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Eye disorders
Diplopia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Intrathecal pump insertion
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscle spasticity
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Spinal cord operation
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Psychiatric disorders
Stress
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Umbilical hernia repair (AE)
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Pneumonia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Influenza
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Peripheral swelling
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Localised infection
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Wound infection
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Antibiotic therapy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Escherichia urinary tract infecti
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Occupational therapy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Physical therapy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Sepsis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Pyrexia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
H1N1 influenza
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Neurological symptom
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Immune system disorders
Sarcoidosis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Surgery
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Vascular stent occlusion
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
Other adverse events
| Measure |
Untreated
n=85 participants at risk
Patients in their first year baseline prior to study drug phase
|
Idebenone
n=39 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Idebenone: idebenone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium povidone, magnesium stearate, silicon dioxide, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
Placebo
n=38 participants at risk
Placebo tablets administered orally as five tablets, three times per day with food.
placebo: lactose monohydrate, microcrystalline cellulose, magnesium stearate, film-coat: Opadry II 85F23495 (consisting of: aluminium lake, FD\&C yellow #6, macrogol/PEG 3550, polyvinylalcohol, titanium dioxide, talc)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
4/85 • Number of events 4 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
7.7%
3/39 • Number of events 4 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
7.9%
3/38 • Number of events 4 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Urinary tract infection
|
5.9%
5/85 • Number of events 8 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Oedema peripheral
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
7.7%
3/39 • Number of events 4 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
7.7%
3/39 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Chest pain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Eye disorders
Retinal detachment
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.1%
2/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Asthenia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Lyme disease
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Catheter management
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Cellulitis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Platelet function test abnormal
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Alanine aminotransferase increase
|
2.4%
2/85 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Aspartate aminotransferase increa
|
2.4%
2/85 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Condition aggravated
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Cholecystectomy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Bacteriuria
|
1.2%
1/85 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Gravitational oedema
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Pain
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Reproductive system and breast disorders
Prostatitis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
White blood cell count increased
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Antiphospholipid antibodies posit
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Aphasia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood creatine phosphokinase abno
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Eye disorders
Cataract
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Psychiatric disorders
Depression
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
General symptom
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Migraine
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Prostatic specific antigen increa
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Retinal function test abnormal
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Somnolence
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Trigeminal nerve ablation
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/39 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Pneumonia
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/85 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Influenza
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Osteoperosis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
5.3%
2/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Peripheral swelling
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood creatine phosphokinase incr
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Body tinea
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Dental caries
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Gamma-glutamyltransferase increas
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Localised infection
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Wound infection
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood glucose increased
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood uric acid increased
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Ear tube insertion
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Genital herpes
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Endocrine disorders
Goitre
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscle injury
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Occult blood positive
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Oral infection
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Sinusitis
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Systemic inflammatory response sy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Tinea versicolor
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/85 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
2.6%
1/38 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
5/85 • Number of events 5 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
General disorders
Pyrexia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Staphylococcal infection
|
1.2%
1/85 • Number of events 3 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Anti-thyroid antibody positive
|
1.2%
1/85 • Number of events 2 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood alkaline phosphatase increa
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood creatinine abnormal
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood creatinine increased
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Blood urine
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Buttock injury
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Renal and urinary disorders
Chromaturia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Cystoscopy
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Surgical and medical procedures
Endodontic procedure
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Eye disorders
Glaucoma
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Glomerular filtration rate increa
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Headache
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Hepatobiliary disorders
Hepatic lesion
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Mean cell volume abnormal
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Nuclear magnetic resonance imagin
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Infections and infestations
Onychomycosis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Vascular disorders
Peripheral venous disease
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Platelet count decreased
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Investigations
Prostate biopsy
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Nervous system disorders
Seizure
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/85 • Number of events 1 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/39 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
0.00%
0/38 • 3 years
First 1 year (Month -12 to Month 0), all patients were untreated - adverse events are reported on all 85 enrolled patients during this pre-treatment phase Next 2 years (Month 0 to Month 24) patients were randomized to placebo (38 patients) or idebenone (39 patients) - adverse events are collected on these 77 patients during the 2 year double-blind phase
|
Additional Information
Dr. Bibiana Bielekova
National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: (240) 669-2724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place