Trial Outcomes & Findings for Arimoclomol in Sporadic Inclusion Body Myositis (NCT NCT00769860)
NCT ID: NCT00769860
Last Updated: 2017-01-19
Results Overview
Measure reflects the total number of adverse events reported during course of the study.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
24 participants
Primary outcome timeframe
Month 12
Results posted on
2017-01-19
Participant Flow
Participant milestones
| Measure |
Arimoclomol
Arimoclomol 100 mg TID for 4 months
|
Placebo
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
Month 4
|
16
|
8
|
|
Overall Study
Month 8
|
14
|
8
|
|
Overall Study
COMPLETED
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arimoclomol
Arimoclomol 100 mg TID for 4 months
|
Placebo
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Arimoclomol in Sporadic Inclusion Body Myositis
Baseline characteristics by cohort
| Measure |
Arimoclomol
n=16 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.85 years
STANDARD_DEVIATION 7.86 • n=93 Participants
|
68.83 years
STANDARD_DEVIATION 6.70 • n=4 Participants
|
66.84 years
STANDARD_DEVIATION 7.49 • n=27 Participants
|
|
Gender
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Gender
Male
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
4 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=93 Participants
|
4 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score
|
27.5 units on a scale
STANDARD_DEVIATION 7.0 • n=93 Participants
|
24.6 units on a scale
STANDARD_DEVIATION 5.1 • n=4 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 6.4 • n=27 Participants
|
|
Manual Muscle Testing (MMT) Score
|
4.2 units on a scale
STANDARD_DEVIATION 0.5 • n=93 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 0.4 • n=27 Participants
|
|
Maximum Isometric Voluntary Contraction Testing (MVICT) Score
|
130.4 newtons
STANDARD_DEVIATION 70.4 • n=93 Participants
|
94.4 newtons
STANDARD_DEVIATION 39.8 • n=4 Participants
|
119.4 newtons
STANDARD_DEVIATION 63.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Month 12Measure reflects the total number of adverse events reported during course of the study.
Outcome measures
| Measure |
Arimoclomol
n=16 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Count of Adverse Events Reported
|
109 adverse events reported
|
52 adverse events reported
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 4Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.
Outcome measures
| Measure |
Arimoclomol
n=15 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Heat Shock Protein 70 (HSP70) Levels in the Tissue
|
-110.72 ng/100ng myosin
Standard Deviation 757.40
|
-34.70 ng/100ng myosin
Standard Deviation 336.35
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 4Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Outcome measures
| Measure |
Arimoclomol
n=15 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Muscle Strength Testing
|
-0.04 units on a scale
Standard Deviation 0.19
|
-0.12 units on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 8Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Outcome measures
| Measure |
Arimoclomol
n=13 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Muscle Strength Testing
|
-0.12 units on a scale
Standard Deviation 0.22
|
-0.26 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.
Outcome measures
| Measure |
Arimoclomol
n=14 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=7 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Muscle Strength Testing
|
-0.21 units on a scale
Standard Deviation 0.21
|
-0.35 units on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 4Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Outcome measures
| Measure |
Arimoclomol
n=16 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score
|
-0.34 units on a scale
Standard Deviation 1.38
|
-0.88 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 8Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Outcome measures
| Measure |
Arimoclomol
n=14 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score
|
-0.68 units on a scale
Standard Deviation 1.58
|
-2.50 units on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12Population: One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.
Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.
Outcome measures
| Measure |
Arimoclomol
n=15 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score
|
-2.03 units on a scale
Standard Deviation 2.68
|
-3.50 units on a scale
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 4Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.
Outcome measures
| Measure |
Arimoclomol
n=14 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Maximum Isometric Voluntary Contraction Testing (MVICT) Score
|
0.46 newtons
Standard Deviation 12.11
|
-0.30 newtons
Standard Deviation 14.49
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 8Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.
Outcome measures
| Measure |
Arimoclomol
n=13 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Maximum Isometric Voluntary Contraction Testing (MVICT) Score
|
7.20 newtons
Standard Deviation 19.65
|
-1.71 newtons
Standard Deviation 17.80
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.
Outcome measures
| Measure |
Arimoclomol
n=14 Participants
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 Participants
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Maximum Isometric Voluntary Contraction Testing (MVICT) Score
|
-1.21 newtons
Standard Deviation 20.76
|
0.52 newtons
Standard Deviation 17.98
|
Adverse Events
Arimoclomol
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arimoclomol
n=16 participants at risk
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 participants at risk
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
Other adverse events
| Measure |
Arimoclomol
n=16 participants at risk
Arimoclomol 100 mg TID for 4 months
|
Placebo
n=8 participants at risk
Matched placebo pills, 100 mg TID for 4 months
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Ear and labyrinth disorders
Dizziness/tinnitus
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Eye disorders
Dry eyes
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
50.0%
4/8 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Throat irritation
|
18.8%
3/16 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Loose stools
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
50.0%
4/8 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Painful parotids
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Bowel movement problems
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Epigastralgia
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Gas pain
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Pyrosis
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Gastrointestinal disorders
Geographic tongue
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
General disorders
Weight loss
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
General disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
General disorders
Loss of consciousness
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Sinus infection
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
31.2%
5/16 • Number of events 7 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 4 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Erysipelas
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Infections and infestations
Leg ulcer infection
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Injury, poisoning and procedural complications
Fall/contusion
|
50.0%
8/16 • Number of events 23 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
62.5%
5/8 • Number of events 9 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Injury, poisoning and procedural complications
Post-biopsy pain
|
18.8%
3/16 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Injury, poisoning and procedural complications
Post-biopsy fatigue
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Injury, poisoning and procedural complications
Pruritus in biopsy scar
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Injury, poisoning and procedural complications
Finger cut
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Investigations
Hyponatremia
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Investigations
High thyroxine levels
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Investigations
Spinal stenosis
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Investigations
Herniated disk
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
37.5%
6/16 • Number of events 10 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
25.0%
2/8 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis flare
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Musculoskeletal and connective tissue disorders
Heat and soreness of proximal lower limbs
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 7 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
25.0%
2/8 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Nervous system disorders
Worsening of restless leg syndrome
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Nervous system disorders
Stroke
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Reproductive system and breast disorders
Decreased libido
|
0.00%
0/16 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Skin and subcutaneous tissue disorders
Insect bite with erythema
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Skin and subcutaneous tissue disorders
Cold sores
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Surgical and medical procedures
Tooth extraction
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
12.5%
1/8 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Surgical and medical procedures
Sinus surgery
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Surgical and medical procedures
Solar lentigines removal
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
0.00%
0/8 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
25.0%
2/8 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
|
Vascular disorders
Edema
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
37.5%
3/8 • Number of events 3 • Adverse event data was collected for the duration of the subject's participation, 12 months.
Participants were assessed at every study visit for adverse experiences. Safety laboratories were collected and monitored for all study participants.
|
Additional Information
Dr. Richard Barohn
University of Kansas Medical Center
Phone: (913) 588-6094
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place