Trial Outcomes & Findings for A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS) (NCT NCT02714036)
NCT ID: NCT02714036
Last Updated: 2024-09-24
Results Overview
Glial activation will be estimated in eligible participants in the Regular arm by combined magnetic resonance positron emission tomography (MR-PET) using the \[11C\]-PBR28 radioligand. \[11C\]-PBR28 uptake is quantified as the ratio of the standardized uptake value (SUVR). An independent neuroimaging rater blinded to the clinical data will assess for quality control of the PBR28-PET images and SUVR. The primary analysis will be performed on the modified Intent-to-Treat (mITT) population. The median (90% confidence interval \[CI\]) changes from baseline in SUVR from pre- to post-treatment visit will be presented.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
12- 24 weeks (post treatment [11C]-PBR28-PET scan will be performed between the Week 12 and Week 24 visits.
Results posted on
2024-09-24
Participant Flow
Analysis Sets: Safety (n=35, n=30 Regular arm, n=5 Flexible arm) = All participants initiated at least the first MN-166 dose. Intent-to-Treat (ITT) (n=30) = All participants initiated at least the first MN-166 dose, excluding Flexible arm. Modified ITT (n=22) = Subset of ITT who completed pre- and post-treatment PET scans. Per Protocol (PP) (n=16) Subset of ITT who successfully titrated up to and maintained the full dose of 50 mg bid.
Participant milestones
| Measure |
Regular
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
5
|
|
Overall Study
COMPLETED
|
18
|
1
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
| Measure |
Regular
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
n=5 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
5 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Mean years since ALS onset
|
2.06 mean years since ALS onset
n=5 Participants
|
1.93 mean years since ALS onset
n=7 Participants
|
2.04 mean years since ALS onset
n=5 Participants
|
|
Mean delay between symptom onset and ALS diagnosis
|
1.12 Mean years
n=5 Participants
|
0.74 Mean years
n=7 Participants
|
1.06 Mean years
n=5 Participants
|
|
Site of ALS onset
Bulbar onset
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Site of ALS onset
Lower Limb
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Site of ALS onset
Upper Limb
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12- 24 weeks (post treatment [11C]-PBR28-PET scan will be performed between the Week 12 and Week 24 visits.Population: modified Intent-to-Treat population
Glial activation will be estimated in eligible participants in the Regular arm by combined magnetic resonance positron emission tomography (MR-PET) using the \[11C\]-PBR28 radioligand. \[11C\]-PBR28 uptake is quantified as the ratio of the standardized uptake value (SUVR). An independent neuroimaging rater blinded to the clinical data will assess for quality control of the PBR28-PET images and SUVR. The primary analysis will be performed on the modified Intent-to-Treat (mITT) population. The median (90% confidence interval \[CI\]) changes from baseline in SUVR from pre- to post-treatment visit will be presented.
Outcome measures
| Measure |
Regular
n=22 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Impact of MN-166 on [11C]-PBR28 Uptake in the Motor Cortices and Brain Stem Measured by Positron Emission Tomography (PET) Imaging at 12 - 24 Weeks
|
0.0015 SUV ratio
Interval -0.0082 to 0.0205
|
—
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Intent-to-Treat population
Mean change from baseline (pre-dose) to Week 36 in blood biomarkers for neuroinflammation, including macrophage migration inhibitory factor (MIF), tumor necrosis factor (TNF)-alpha, and neurofilament light (NfL). All blood biomarkers are measured in picograms/milliliter (pg/mL).
Outcome measures
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Impact of MN-166 on Several Markers of Neuro-inflammation Measured by Blood Biomarkers at Week 36
macrophage migration inhibitory factor
|
-673387.22 picograms/milliliters
Standard Deviation 943313.53
|
—
|
|
Impact of MN-166 on Several Markers of Neuro-inflammation Measured by Blood Biomarkers at Week 36
tumor necrosis factor-alpha
|
-0.31 picograms/milliliters
Standard Deviation 0.57
|
—
|
|
Impact of MN-166 on Several Markers of Neuro-inflammation Measured by Blood Biomarkers at Week 36
neurofilament light
|
21.43 picograms/milliliters
Standard Deviation 47.71
|
—
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Safety population
Clinical and laboratory treatment-emergent adverse events (TEAEs) will be collected and stratified by severity, persistence over time, and relationship to study drug.
Outcome measures
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
n=5 Participants
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Safety and Tolerability of MN-166 Over 36 Weeks
|
30 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Intent-to-Treat population
Mean change from baseline to Week 36 on ALSFRS-R score. ALSFRS-R rating scale is a tool to assess patient's capability and independence in 12 functional activities. The ALSFRS-R total score is a composite of sub-scores measuring speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing and hygiene, turning in bed and adjusting bed clothes, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency. Each subscale ranges from 0 (no ability) to 4 (normal ability). The ALSFRS-R score is the sum total ranging from 0 (zero) to 48, with higher scores meaning better outcome.
Outcome measures
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Evaluate the Effect of MN-166 on ALS Clinical Outcomes (ALS Functional Rating Scale-revised [ALSFRS-R]) Over 36 Weeks.
|
-4.5 Total ALSFRS-R score
Standard Deviation 4.5
|
—
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Intent-to-Treat population
Slow vital capacity (SVC) is the maximum volume of air that can be slowly exhaled after slow, maximal inhalation, measured in liters. The maximum volume expired is converted to percent of predicted (% pred.) normal volume. Higher SVC (% pred.) normal volume indicates better pulmonary function. The results below reflect the mean change in SVC (% pred.) from baseline to week 36.
Outcome measures
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Mean Change From Baseline in Slow Vital Capacity (Percent Predicted) Normal Volume at Week 36
|
-9.27 percent predicted normal volume
Standard Deviation 11.23
|
—
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Intent-to-Treat population
HHD assesses isometric strength using a MicroFET2 hand-held dynamometer in kilograms (kg). To calculate megascores, the mean and standard deviation of each muscle group, without regard to laterality, is calculated from the baseline assessment. Nine upper and lower extremity muscles or muscle groups were examined: shoulder flexion, elbow flexion, wrist extension, first dorsal interosseous contraction, hip flexion, knee extension, and ankle dorsiflexion. Each group was measured at least twice bilaterally and the average of the 2 highest measurements were analyzed. To calculate megascores, the mean and standard deviation of each group were calculated from baseline.
Outcome measures
| Measure |
Regular
n=30 Participants
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
Participants will receive MN-166 up to 100 mg/day for 36 weeks. MN-166 dosing may vary based on individual tolerability. Participants will have all assessments except PET scans.
|
|---|---|---|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
upper limbs, proximal
|
-0.5803 kilograms
Standard Deviation 0.8108
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
upper limbs, distal
|
-0.5004 kilograms
Standard Deviation 0.4823
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
upper limbs, cumulated
|
-0.5324 kilograms
Standard Deviation 0.5738
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
lower limbs, proximal
|
-0.2778 kilograms
Standard Deviation 0.7749
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
lower limbs, distal
|
-0.3525 kilograms
Standard Deviation 0.6492
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
lower limbs, cumulated
|
-0.3151 kilograms
Standard Deviation 0.6824
|
—
|
|
Mean Change From Baseline in Isometric Strength as Measured by Hand-held Dynamometry (HHD) at Week 36.
cumulated
|
-0.4358 kilograms
Standard Deviation 0.5863
|
—
|
Adverse Events
Regular
Serious events: 6 serious events
Other events: 30 other events
Deaths: 2 deaths
Flexible
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regular
n=30 participants at risk
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
n=5 participants at risk
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
Participants will have all assessments except PET scans.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Infections and infestations
Localized infection
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Nervous system disorders
Unresponsive to stimuli
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
Other adverse events
| Measure |
Regular
n=30 participants at risk
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
|
Flexible
n=5 participants at risk
Participants will receive up to 100 mg /day MN-166 for 36 weeks. MN-166 dosing may vary based on individual tolerability.
Participants will have all assessments except PET scans.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
43.3%
13/30 • Number of events 13 • 36 weeks
|
60.0%
3/5 • Number of events 3 • 36 weeks
|
|
Gastrointestinal disorders
dysphagia
|
26.7%
8/30 • Number of events 8 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
5/30 • Number of events 5 • 36 weeks
|
40.0%
2/5 • Number of events 2 • 36 weeks
|
|
Gastrointestinal disorders
vomiting
|
20.0%
6/30 • Number of events 6 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
salivary hypersecretion
|
13.3%
4/30 • Number of events 4 • 36 weeks
|
40.0%
2/5 • Number of events 2 • 36 weeks
|
|
Gastrointestinal disorders
abdominal discomfort
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
abdominal pain upper
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
constipation
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
flatulence
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Gastrointestinal disorders
abdominal rigidity
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
defecation urgency
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Nervous system disorders
headache
|
20.0%
6/30 • Number of events 6 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Nervous system disorders
dizziness
|
20.0%
6/30 • Number of events 6 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Nervous system disorders
dysarthria
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Nervous system disorders
restless leg syndrome
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Nervous system disorders
slow speech
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Nervous system disorders
dysgeugia
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Injury, poisoning and procedural complications
fall
|
50.0%
15/30 • Number of events 15 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Injury, poisoning and procedural complications
contusion
|
13.3%
4/30 • Number of events 4 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Injury, poisoning and procedural complications
skin abrasion
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Injury, poisoning and procedural complications
stoma site erythema
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
General disorders
fatigue
|
36.7%
11/30 • Number of events 11 • 36 weeks
|
40.0%
2/5 • Number of events 2 • 36 weeks
|
|
General disorders
chest discomfort
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
General disorders
edema peripheral
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
General disorders
pain
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
General disorders
disease progression
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
16.7%
5/30 • Number of events 5 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
periarthritis
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
60.0%
3/5 • Number of events 3 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
choking
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Psychiatric disorders
insomnia
|
16.7%
5/30 • Number of events 5 • 36 weeks
|
40.0%
2/5 • Number of events 2 • 36 weeks
|
|
Psychiatric disorders
depressed mood
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
pruritus
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
60.0%
3/5 • Number of events 3 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
rash papular
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
rash pruritic
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
20.0%
6/30 • Number of events 6 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Infections and infestations
oral candidiasis
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Infections and infestations
urinary tract infection
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Metabolism and nutrition disorders
decreased appetite
|
23.3%
7/30 • Number of events 7 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Metabolism and nutrition disorders
dehydration
|
6.7%
2/30 • Number of events 2 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Vascular disorders
hot flush
|
20.0%
6/30 • Number of events 6 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Vascular disorders
deep vein thrombosis
|
10.0%
3/30 • Number of events 3 • 36 weeks
|
0.00%
0/5 • 36 weeks
|
|
Vascular disorders
flushing
|
3.3%
1/30 • Number of events 1 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Investigations
weight decreased
|
13.3%
4/30 • Number of events 4 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Renal and urinary disorders
chromaturia
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
|
Renal and urinary disorders
urine odor abnormal
|
0.00%
0/30 • 36 weeks
|
20.0%
1/5 • Number of events 1 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place