Trial Outcomes & Findings for Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis (NCT NCT01982942)
NCT ID: NCT01982942
Last Updated: 2020-07-28
Results Overview
To evaluate the activity of ibudilast (100 mg/day) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), calculated as the ratio of brain parenchymal tissue volume to the total volume contained within the brain surface contour.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
96 weeks
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Ibudilast
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
126
|
|
Overall Study
COMPLETED
|
108
|
112
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
Reasons for withdrawal
| Measure |
Ibudilast
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Multiple sclerosis progression
|
3
|
2
|
|
Overall Study
Wanted to try therapy not permitted
|
1
|
0
|
|
Overall Study
Subject declined future visits
|
0
|
1
|
|
Overall Study
Left geographical area
|
2
|
0
|
|
Overall Study
Too many pills
|
1
|
0
|
|
Overall Study
MS Relapse
|
0
|
1
|
|
Overall Study
Chose to join a stem cell trial
|
0
|
1
|
|
Overall Study
Subject bedridden, rapidly declining
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Ibudilast
n=129 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=126 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years)
|
54.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
126 participants
n=7 Participants
|
255 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: Modified intent-to-treat is the primary population for efficacy analysis, defined as all participants from the intent-to-treat population (all participants randomly assigned) who received at least one dose of study medication, have at least one efficacy assessment for at least one primary or secondary parameter in the double-blind treatment phase.
To evaluate the activity of ibudilast (100 mg/day) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), calculated as the ratio of brain parenchymal tissue volume to the total volume contained within the brain surface contour.
Outcome measures
| Measure |
Ibudilast
n=103 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=111 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF).
|
-0.00168 ratio
Interval -0.00288 to -0.00048
|
-0.00392 ratio
Interval -0.00491 to -0.00293
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: Safety analysis population: comprises all subjects who received at least one dose of study medication. This is the population for all safety analyses, and subjects were analyzed based on the treatment they received.
Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results.
Outcome measures
| Measure |
Ibudilast
n=129 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=126 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Adverse Events.
|
92.2 percentage receiving study medication
Interval 87.2 to 95.7
|
88.1 percentage receiving study medication
Interval 82.3 to 92.5
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: modified intent-to-treat population
Diffusion tensor imaging estimates the three-dimensional diffusion of water in brain tissue and has been explored as an outcome in MS.
Outcome measures
| Measure |
Ibudilast
n=103 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=111 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts
Left axial diffusivity mean
|
0.0001 10^3/mm^2/s
Interval -0.0068 to 0.007
|
-0.0006 10^3/mm^2/s
Interval -0.0074 to 0.0061
|
|
Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts
Left radial diffusivity mean
|
-0.0077 10^3/mm^2/s
Interval -0.0131 to -0.0023
|
0.0027 10^3/mm^2/s
Interval -0.0026 to 0.0081
|
|
Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts
Right axial diffusivity mean
|
0.0014 10^3/mm^2/s
Interval -0.0055 to 0.0084
|
-0.0017 10^3/mm^2/s
Interval -0.0085 to 0.0051
|
|
Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts
Right radial diffusivity mean
|
-0.0029 10^3/mm^2/s
Interval -0.0088 to 0.0031
|
0.0046 10^3/mm^2/s
Interval -0.0012 to 0.0104
|
SECONDARY outcome
Timeframe: 96 weeksPopulation: Modified intent-to-treat is the primary population for efficacy analysis, defined as all participants from the intent-to-treat population (all participants randomly assigned) who received at least one dose of study medication, have at least one efficacy assessment for at least one primary or secondary parameter in the double-blind treatment phase.
A magnetization transfer MRI as a marker of brain myelin content including the cerebral cortex could be useful. MT imaging provides access to the restricted protons, which are located in biologically interesting tissue regions.Cortical and normal appearing grey matter MTR correlates strongly with measures of disability such as the multiple sclerosis functional composite score and can show treatment effects.
Outcome measures
| Measure |
Ibudilast
n=95 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=103 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Magnetization Transfer Ratio (MTR) Imaging in Normal-appearing Brain Tissue
|
0.325 ratio
Interval 0.285 to 0.365
|
0.247 ratio
Interval 0.195 to 0.299
|
SECONDARY outcome
Timeframe: 96 weeksPopulation: Modified intent-to-treat is the primary population for efficacy analysis, defined as all participants from the intent-to-treat population (all participants randomly assigned) who received at least one dose of study medication, have at least one efficacy assessment for at least one primary or secondary parameter in the double-blind treatment phase.
Mean retinal nerve fiber layer thickness from baseline measured by Optical coherence tomography (OCT), a non-invasive imaging technique used to obtain high-resolution cross-sectional images of the retina. Increase in thickness is considered improvement.
Outcome measures
| Measure |
Ibudilast
n=94 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=103 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Retinal Nerve Fiber Layer as Measured by Optical Coherence Tomography (OCT).
|
83.0 micrometers
Interval 80.7 to 85.2
|
79.5 micrometers
Interval 77.2 to 81.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 weeksPopulation: Modified intent-to-treat is the primary population for efficacy analysis, defined as all participants from the intent-to-treat population (all participants randomly assigned) who received at least one dose of study medication, have at least one efficacy assessment for at least one primary or secondary parameter in the double-blind treatment phase.
New T1 lesions since baseline as measured by least square mean (90% confidence interval).
Outcome measures
| Measure |
Ibudilast
n=102 Participants
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=110 Participants
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
New T1 Lesions Since Baseline
|
0.355 lesions
Interval 0.202 to 0.507
|
0.317 lesions
Interval 0.17 to 0.463
|
Adverse Events
Ibudilast
Serious events: 20 serious events
Other events: 119 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 24 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibudilast
n=129 participants at risk
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=126 participants at risk
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Nervous system disorders
ataxia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Metabolism and nutrition disorders
dehydration
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Nervous system disorders
cerebral haemorrhage
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
General disorders
Pain
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Infections and infestations
cystitis
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Infections and infestations
urinary tract infection
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Metabolism and nutrition disorders
hypercalcemia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
fracture
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cervix carcinoma stage 0
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Nervous system disorders
spondylitic myelopathy
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
General disorders
Asthenia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Hepatobiliary disorders
febrile neutropenia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Cardiac disorders
myocardial infarction
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Infections and infestations
sepsis
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic malignant melanoma
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Hepatobiliary disorders
colelithiais
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Gastrointestinal disorders
colonic obstruction
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
endometrial cancer
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Endocrine disorders
parotidectomy
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Gastrointestinal disorders
intestinal obstraction
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Renal and urinary disorders
bladder prolapse
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Renal and urinary disorders
kideny infection
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder transitional cell cancer
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Infections and infestations
tooth infection
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Nervous system disorders
convulsion
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
cervical spinal stenosis
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
injury
|
0.00%
0/129 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
Other adverse events
| Measure |
Ibudilast
n=129 participants at risk
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
|
Placebo Oral Capsule
n=126 participants at risk
Subjects will receive placebo for 96 weeks.
Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
3.2%
4/126 • Number of events 7 • 100 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/129 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
2/129 • Number of events 3 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Eye disorders
Conjunctivitis
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Gastrointestinal disorders
Nausea
|
27.1%
35/129 • Number of events 39 • 100 weeks
|
15.1%
19/126 • Number of events 21 • 100 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
14.7%
19/129 • Number of events 21 • 100 weeks
|
6.3%
8/126 • Number of events 9 • 100 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
9/129 • Number of events 10 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.2%
8/129 • Number of events 10 • 100 weeks
|
5.6%
7/126 • Number of events 7 • 100 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
6/129 • Number of events 7 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
5/129 • Number of events 5 • 100 weeks
|
2.4%
3/126 • Number of events 6 • 100 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.9%
5/129 • Number of events 5 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
0.79%
1/126 • Number of events 3 • 100 weeks
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
4.8%
6/126 • Number of events 6 • 100 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
4.0%
5/126 • Number of events 5 • 100 weeks
|
|
General disorders
Fatigue
|
10.9%
14/129 • Number of events 14 • 100 weeks
|
7.9%
10/126 • Number of events 11 • 100 weeks
|
|
General disorders
Oedema peripheral
|
3.9%
5/129 • Number of events 6 • 100 weeks
|
4.8%
6/126 • Number of events 6 • 100 weeks
|
|
General disorders
Irritability
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
General disorders
Chest pain
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
General disorders
Influenza like illness
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Infections and infestations
Urinary tract infection
|
27.1%
35/129 • Number of events 67 • 100 weeks
|
34.1%
43/126 • Number of events 88 • 100 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
13/129 • Number of events 17 • 100 weeks
|
19.0%
24/126 • Number of events 26 • 100 weeks
|
|
Infections and infestations
Sinusitis
|
3.9%
5/129 • Number of events 7 • 100 weeks
|
4.8%
6/126 • Number of events 7 • 100 weeks
|
|
Infections and infestations
Bronchitis
|
3.9%
5/129 • Number of events 5 • 100 weeks
|
3.2%
4/126 • Number of events 5 • 100 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
5/129 • Number of events 6 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Infections and infestations
Tooth infection
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Infections and infestations
Influenza
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Infections and infestations
Influenza like illness
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
7.1%
9/126 • Number of events 10 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/129 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
22.5%
29/129 • Number of events 63 • 100 weeks
|
15.9%
20/126 • Number of events 35 • 100 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
4.7%
6/129 • Number of events 7 • 100 weeks
|
5.6%
7/126 • Number of events 8 • 100 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
4.7%
6/129 • Number of events 8 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.9%
5/129 • Number of events 6 • 100 weeks
|
4.0%
5/126 • Number of events 5 • 100 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Investigations
Urine analysis abnormal
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
3.2%
4/126 • Number of events 4 • 100 weeks
|
|
Investigations
Hepatic enzyme increased
|
3.1%
4/129 • Number of events 5 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Investigations
Lymphocyte count decreased
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Investigations
White blood cell count decreased
|
3.1%
4/129 • Number of events 5 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Investigations
Gamma-glutamyl transferase increased
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Investigations
Weight decreased
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
2/129 • Number of events 3 • 100 weeks
|
3.2%
4/126 • Number of events 4 • 100 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
8/129 • Number of events 9 • 100 weeks
|
3.2%
4/126 • Number of events 4 • 100 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.5%
11/129 • Number of events 13 • 100 weeks
|
9.5%
12/126 • Number of events 15 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
10/129 • Number of events 11 • 100 weeks
|
11.9%
15/126 • Number of events 16 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
10/129 • Number of events 11 • 100 weeks
|
7.9%
10/126 • Number of events 12 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
5/129 • Number of events 6 • 100 weeks
|
10.3%
13/126 • Number of events 15 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 3 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/129 • 100 weeks
|
3.2%
4/126 • Number of events 4 • 100 weeks
|
|
Nervous system disorders
Headache
|
17.8%
23/129 • Number of events 29 • 100 weeks
|
11.9%
15/126 • Number of events 19 • 100 weeks
|
|
Nervous system disorders
Muscle spasticity
|
7.0%
9/129 • Number of events 9 • 100 weeks
|
9.5%
12/126 • Number of events 13 • 100 weeks
|
|
Nervous system disorders
Paraesthesia
|
7.0%
9/129 • Number of events 11 • 100 weeks
|
6.3%
8/126 • Number of events 8 • 100 weeks
|
|
Nervous system disorders
Dizziness
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Nervous system disorders
Tremor
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
0.00%
0/126 • 100 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Psychiatric disorders
Insomnia
|
10.9%
14/129 • Number of events 16 • 100 weeks
|
8.7%
11/126 • Number of events 11 • 100 weeks
|
|
Psychiatric disorders
Depression
|
9.3%
12/129 • Number of events 15 • 100 weeks
|
3.2%
4/126 • Number of events 4 • 100 weeks
|
|
Psychiatric disorders
Anxiety
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.1%
4/129 • Number of events 5 • 100 weeks
|
5.6%
7/126 • Number of events 7 • 100 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
3.2%
4/126 • Number of events 5 • 100 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/129 • Number of events 1 • 100 weeks
|
2.4%
3/126 • Number of events 3 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
8/129 • Number of events 10 • 100 weeks
|
6.3%
8/126 • Number of events 8 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.7%
6/129 • Number of events 6 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
1.6%
2/126 • Number of events 3 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
3/129 • Number of events 3 • 100 weeks
|
0.79%
1/126 • Number of events 1 • 100 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.6%
2/129 • Number of events 2 • 100 weeks
|
2.4%
3/126 • Number of events 4 • 100 weeks
|
|
Vascular disorders
Hot flush
|
3.9%
5/129 • Number of events 5 • 100 weeks
|
1.6%
2/126 • Number of events 2 • 100 weeks
|
|
Vascular disorders
Hypertension
|
3.1%
4/129 • Number of events 4 • 100 weeks
|
5.6%
7/126 • Number of events 7 • 100 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60