Trial Outcomes & Findings for Idebenone for Primary Progressive Multiple Sclerosis (NCT NCT01854359)
NCT ID: NCT01854359
Last Updated: 2021-05-19
Results Overview
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 study groups (Active treatment group in the 09-I-0197 trial and Placebo group in the 09-I-0197) as follows: 1. pre-treatment baseline during the 09-I-0197 trial (from Months -12, -6, and 0) 2. double-blind phase during the 09-I-0197 trial (from Months 0, 6, 12, 18, and 24) 3. extension phase during the 13-I-0088 trial (from Months 24, 30, and 36) 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.
COMPLETED
PHASE1/PHASE2
61 participants
1-year pre-treatment baseline vs 2-year randomized double-blind phased vs 1-year treatment period
2021-05-19
Participant Flow
Participant milestones
| Measure |
Active Treatment in 09-I-0197
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
This group completed a total of 3 years of Idebenone treatment
|
Placebo in 09-I-0197
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
This group completed a total of 1 year of Idebenone treatment (following 2 years of placebo treatment in the 09-I-0198 trial).
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Idebenone for Primary Progressive Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Active Treatment in 09-I-0197
n=31 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
This group completed a total of 3 years of Idebenone treatment.
|
Placebo in 09-I-0197
n=30 Participants
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
This group completed a total of 1 year of Idebenone treatment (following 2 years of placebo treatment in the 09-I-0197 trial)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
59.2 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
59.6 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1-year pre-treatment baseline vs 2-year randomized double-blind phased vs 1-year treatment periodPopulation: 61 subjects that completed three year 09-I-0197 trial enrolled into the one year open-label extension phase of the 13-I-0088. Out of the 61 subjects, 31 were assigned to the active treatment group in the 09-I-0197 trial and 30 received placebo. The 09-I-1097 consisted of one-year pre-treatment baseline and 2 years of double-blind treatment phase.
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 study groups (Active treatment group in the 09-I-0197 trial and Placebo group in the 09-I-0197) as follows: 1. pre-treatment baseline during the 09-I-0197 trial (from Months -12, -6, and 0) 2. double-blind phase during the 09-I-0197 trial (from Months 0, 6, 12, 18, and 24) 3. extension phase during the 13-I-0088 trial (from Months 24, 30, and 36) 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 |
Pre-treatment Baseline (Placebo Group)
n=30 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
|
Double-blind Phase (Placebo Group)
n=30 Participants
Two-Year Double-blind Phase of 09-I-0197 (placebo group)
|
Extension Phase (Placebo Group)
n=22 Participants
One-year open label active treatment group that received placebo in the 09-I-0197 trial
|
Pre-treatment Baseline (Active Treatment Group)
n=31 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
|
Double-blind Phase (Active Treatment Group)
n=31 Participants
Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
|
Extension Phase (Active Treatment Group)
n=26 Participants
One-year open label active treatment group that received active treatment in the 09-I-0197 trial
|
|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE)
|
1.55 units on a scale * year
Standard Deviation 2.02
|
0.80 units on a scale * year
Standard Deviation 1.96
|
0.46 units on a scale * year
Standard Deviation 1.93
|
0.89 units on a scale * year
Standard Deviation 1.81
|
0.75 units on a scale * year
Standard Deviation 1.82
|
1.30 units on a scale * year
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: 3-years double-blind phase and 1-year extension phasePopulation: 61 subjects that completed three year 09-I-0197 trial enrolled into the one year open-label extension phase of the 13-I-0088. Out of the 61 subjects, 31 were assigned to the active treatment group in the 09-I-0197 trial and 30 received placebo. The 09-I-1097 consisted of one-year pre-treatment baseline and 2 years of double-blind treatment phase.
slopes of measured times of 25FW during the 3-year 09-I-0197 trial (one year of pre-treatment baseline and two years of double-blind randomized treatment) and during one year extension phase of the 13-I-0088 trial. The slopes were measured separately for placebo and active treatment arm as randomized in the the 09-I-0197 trial. Lower extremity disability was measured by an average of two trials of timed 25 foot walk assessed every 6 month. 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 |
Pre-treatment Baseline (Placebo Group)
n=30 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
|
Double-blind Phase (Placebo Group)
n=22 Participants
Two-Year Double-blind Phase of 09-I-0197 (placebo group)
|
Extension Phase (Placebo Group)
n=31 Participants
One-year open label active treatment group that received placebo in the 09-I-0197 trial
|
Pre-treatment Baseline (Active Treatment Group)
n=26 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
|
Double-blind Phase (Active Treatment Group)
Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
|
Extension Phase (Active Treatment Group)
One-year open label active treatment group that received active treatment in the 09-I-0197 trial
|
|---|---|---|---|---|---|---|
|
Slopes of 25 Foot Walk (25FW) Time
|
0.04322 seconds per year
Standard Error 0.009617
|
-0.00531 seconds per year
Standard Error 0.01599
|
0.04031 seconds per year
Standard Error 0.0106
|
0.03401 seconds per year
Standard Error 0.01286
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-years double-blind phase and 1-year extension phasePopulation: 61 subjects that completed three year 09-I-0197 trial enrolled into the one year open-label extension phase of the 13-I-0088. Out of the 61 subjects, 31 were assigned to the active treatment group in the 09-I-0197 trial and 30 received placebo. The 09-I-1097 consisted of one-year pre-treatment baseline and 2 years of double-blind treatment phase.
Slopes of measured times of 9HPT during the 3-year 09-I-0197 trial (one year of pre-treatment baseline and two years of double-blind randomized treatment) and during one year extension phase of the 13-I-0088 trial. The slopes were measured separately for placebo and active treatment arm as randomized in the the 09-I-0197 trial. 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 every 6 months.
Outcome measures
| Measure |
Pre-treatment Baseline (Placebo Group)
n=30 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
|
Double-blind Phase (Placebo Group)
n=22 Participants
Two-Year Double-blind Phase of 09-I-0197 (placebo group)
|
Extension Phase (Placebo Group)
n=31 Participants
One-year open label active treatment group that received placebo in the 09-I-0197 trial
|
Pre-treatment Baseline (Active Treatment Group)
n=26 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
|
Double-blind Phase (Active Treatment Group)
Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
|
Extension Phase (Active Treatment Group)
One-year open label active treatment group that received active treatment in the 09-I-0197 trial
|
|---|---|---|---|---|---|---|
|
Slopes of 9 Hole Peg Test (9HPT) Time
|
0.000665 seconds per year
Standard Error 0.000491
|
0.000947 seconds per year
Standard Error 0.001189
|
0.000718 seconds per year
Standard Error 0.000462
|
0.001086 seconds per year
Standard Error 0.000614
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-years double-blind phase and 1-year extension phasePopulation: 61 subjects that completed three year 09-I-0197 trial enrolled into the one year open-label extension phase of the 13-I-0088. Out of the 61 subjects, 31 were assigned to the active treatment group in the 09-I-0197 trial and 30 received placebo. The 09-I-1097 consisted of one-year pre-treatment baseline and 2 years of double-blind treatment phase.
Slopes of measured EDSS scores during the 3-year 09-I-0197 trial (one year of pre-treatment baseline and two years of double-blind randomized treatment) and during one year extension phase of the 13-I-0088 trial. The slopes were measured separately for placebo and active treatment arm as randomized in the the 09-I-0197 trial. 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 Multiple Sclerosis (MS). EDSS was assessed every 6 months.
Outcome measures
| Measure |
Pre-treatment Baseline (Placebo Group)
n=30 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
|
Double-blind Phase (Placebo Group)
n=22 Participants
Two-Year Double-blind Phase of 09-I-0197 (placebo group)
|
Extension Phase (Placebo Group)
n=31 Participants
One-year open label active treatment group that received placebo in the 09-I-0197 trial
|
Pre-treatment Baseline (Active Treatment Group)
n=26 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
|
Double-blind Phase (Active Treatment Group)
Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
|
Extension Phase (Active Treatment Group)
One-year open label active treatment group that received active treatment in the 09-I-0197 trial
|
|---|---|---|---|---|---|---|
|
Slopes of Expanded Disability Status Scale (EDSS) Score
|
0.1447 score on a scale per year
Standard Error 0.05778
|
0.1435 score on a scale per year
Standard Error 0.07625
|
0.1107 score on a scale per year
Standard Error 0.03651
|
0.1584 score on a scale per year
Standard Error 0.09479
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-years double-blind phase and 1-year extension phasePopulation: 61 subjects that completed three year 09-I-0197 trial enrolled into the one year open-label extension phase of the 13-I-0088. Out of the 61 subjects, 31 were assigned to the active treatment group in the 09-I-0197 trial and 30 received placebo. The 09-I-1097 consisted of one-year pre-treatment baseline and 2 years of double-blind treatment phase.
Slopes of measured SNRS scores during the 3-year 09-I-0197 trial (one year of pre-treatment baseline and two years of double-blind randomized treatment) and during one year extension phase of the 13-I-0088 trial. The slopes were measured separately for placebo and active treatment arm as randomized in the the 09-I-0197 trial. 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 every 6 months.
Outcome measures
| Measure |
Pre-treatment Baseline (Placebo Group)
n=30 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for placebo group
|
Double-blind Phase (Placebo Group)
n=22 Participants
Two-Year Double-blind Phase of 09-I-0197 (placebo group)
|
Extension Phase (Placebo Group)
n=31 Participants
One-year open label active treatment group that received placebo in the 09-I-0197 trial
|
Pre-treatment Baseline (Active Treatment Group)
n=26 Participants
One Year Pre-treatment baseline of the 09-I-0197 trial for active treatment group
|
Double-blind Phase (Active Treatment Group)
Two-Year Double-blind Phase of 09-I-0197 (active treatment group)
|
Extension Phase (Active Treatment Group)
One-year open label active treatment group that received active treatment in the 09-I-0197 trial
|
|---|---|---|---|---|---|---|
|
Change in Slopes of Scripps Neurological Rating Scale (SNRS) Score
|
-1.8838 score on a scale per year
Standard Error 0.4829
|
-2.1655 score on a scale per year
Standard Error 1.0735
|
-2.009 score on a scale per year
Standard Error 0.3789
|
-2.7263 score on a scale per year
Standard Error 1.0073
|
—
|
—
|
Adverse Events
Active Treatment in 09-I-0197
Placebo in 09-I-0197
Serious adverse events
| Measure |
Active Treatment in 09-I-0197
n=31 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Two years of Idebenone treatment during the 09-I-0197 double-blind phase
|
Placebo in 09-I-0197
n=30 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Two years of placebo during the 09-I-0197 double-blind phase
|
|---|---|---|
|
Blood and lymphatic system disorders
Elevated liver enzynes
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Cardiac disorders
decreased ejection fraction
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Gastrointestinal disorders
stomach cancer
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Gastrointestinal disorders
severe constipation
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Hepatobiliary disorders
gallstones
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Infections and infestations
ruptured apendix
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Injury, poisoning and procedural complications
broken ribs
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Injury, poisoning and procedural complications
broken femur
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Cardiac disorders
chest tightness
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
Other adverse events
| Measure |
Active Treatment in 09-I-0197
n=31 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Two years of Idebenone treatment during the 09-I-0197 double-blind phase
|
Placebo in 09-I-0197
n=30 participants at risk
Idebenone (150mg tablets) administered orally as five tablets, three times per day with food.
Two years of placebo during the 09-I-0197 double-blind phase
|
|---|---|---|
|
Injury, poisoning and procedural complications
fall
|
3.2%
1/31 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
20.0%
6/30 • Number of events 7 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Injury, poisoning and procedural complications
fractured bone
|
9.7%
3/31 • Number of events 3 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Skin and subcutaneous tissue disorders
hair loss
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Cardiac disorders
hypertension
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
General disorders
increased mobility problems
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Injury, poisoning and procedural complications
injured meniscus
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
6.7%
2/30 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Infections and infestations
penumonia
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Musculoskeletal and connective tissue disorders
radiculopathy
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Eye disorders
retinal detachment
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
6.7%
2/30 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Eye disorders
transient graying of vision
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Infections and infestations
urinary tract infection
|
6.5%
2/31 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
10.0%
3/30 • Number of events 3 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.5%
2/31 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Skin and subcutaneous tissue disorders
basal cell carcinoma
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Endocrine disorders
benign thyroid nodule
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Cardiac disorders
chest pain
|
3.2%
1/31 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Metabolism and nutrition disorders
dehydration
|
3.2%
1/31 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
0.00%
0/30 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
6.7%
2/30 • Number of events 2 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
|
Musculoskeletal and connective tissue disorders
edema
|
0.00%
0/31 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
3.3%
1/30 • Number of events 1 • 1 year
Adverse events are collected on 61 patients enrolled in the 1-year open-label phase
|
Additional Information
Dr. Peter Kosa (Staff Scientist)
National Institutes of Allergy and Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place