Trial Outcomes & Findings for OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity (NCT NCT02145676)
NCT ID: NCT02145676
Last Updated: 2017-04-12
Results Overview
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
53 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA 500U
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 10.36 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 10.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
Baseline
|
4.12 Scores on a Scale
Standard Deviation 0.332
|
4.06 Scores on a Scale
Standard Deviation 0.236
|
4.17 Scores on a Scale
Standard Deviation 0.383
|
|
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
Change from Baseline at Week 6
|
-1.62 Scores on a Scale
Standard Deviation 1.455
|
-1.47 Scores on a Scale
Standard Deviation 1.247
|
-0.74 Scores on a Scale
Standard Deviation 0.970
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
Baseline
|
4.00 Scores on a Scale
Standard Deviation 0.000
|
4.06 Scores on a Scale
Standard Deviation 0.236
|
4.00 Scores on a Scale
Standard Deviation 0.000
|
|
Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
Change from Baseline at Week 6
|
-1.59 Scores on a Scale
Standard Deviation 1.263
|
-1.39 Scores on a Scale
Standard Deviation 1.042
|
-1.44 Scores on a Scale
Standard Deviation 1.004
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score \>0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=11 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=10 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=13 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pain on an 11-Point Scale
Baseline
|
4.89 Scores on a Scale
Standard Deviation 2.714
|
6.05 Scores on a Scale
Standard Deviation 3.197
|
5.13 Scores on a Scale
Standard Deviation 3.586
|
|
Change From Baseline in Pain on an 11-Point Scale
Change from Baseline at Week 6
|
-2.08 Scores on a Scale
Standard Deviation 3.585
|
-2.51 Scores on a Scale
Standard Deviation 4.606
|
-2.64 Scores on a Scale
Standard Deviation 3.857
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Baseline
|
2.61 Scores on a Scale
Standard Deviation 1.346
|
2.91 Scores on a Scale
Standard Deviation 1.123
|
2.82 Scores on a Scale
Standard Deviation 1.092
|
|
Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Change from Baseline at Week 6
|
-0.36 Scores on a Scale
Standard Deviation 0.854
|
-0.27 Scores on a Scale
Standard Deviation 0.932
|
-0.55 Scores on a Scale
Standard Deviation 1.082
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Baseline
|
2.71 Scores on a Scale
Standard Deviation 1.231
|
2.69 Scores on a Scale
Standard Deviation 1.263
|
2.58 Scores on a Scale
Standard Deviation 1.188
|
|
Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Change from Baseline at Week 6
|
-0.62 Scores on a Scale
Standard Deviation 1.147
|
-0.36 Scores on a Scale
Standard Deviation 1.247
|
-0.51 Scores on a Scale
Standard Deviation 1.064
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.
Outcome measures
| Measure |
onabotulinumtoxinA 500U
n=17 Participants
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 Participants
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 Participants
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Baseline
|
2.58 Scores on a Scale
Standard Deviation 1.234
|
2.61 Scores on a Scale
Standard Deviation 1.189
|
2.61 Scores on a Scale
Standard Deviation 1.086
|
|
Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Change from Baseline at Week 6
|
-0.26 Scores on a Scale
Standard Deviation 0.779
|
-0.21 Scores on a Scale
Standard Deviation 0.667
|
-0.48 Scores on a Scale
Standard Deviation 1.094
|
Adverse Events
onabotulinumtoxinA 500U
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
onabotulinumtoxinA 300U
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Normal Saline)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA 500U
n=17 participants at risk
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 participants at risk
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 participants at risk
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
7.7%
1/13
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/8
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
Other adverse events
| Measure |
onabotulinumtoxinA 500U
n=17 participants at risk
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
|
onabotulinumtoxinA 300U
n=18 participants at risk
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
|
Placebo (Normal Saline)
n=18 participants at risk
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Seizure
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Investigations
Electromyogram abnormal
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Immune system disorders
Seasonal allergy
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Sialoadenitis
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/17
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER