Trial Outcomes & Findings for Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia (NCT NCT02217332)
NCT ID: NCT02217332
Last Updated: 2021-05-18
Results Overview
Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 6 is presented as ratio to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2021-05-18
Participant Flow
During a screening period of between 14 and 21 days, subjects were monitored symptoms of sinusitis and asthma. Subject who failed to meet the eligibility criteria during the screening period were disqualified.
Participant milestones
| Measure |
Dexpramipexole
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Dexpramipexole
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Dose interruption >1 month
|
1
|
|
Overall Study
Protocol Violation (eligibility)
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Baseline characteristics by cohort
| Measure |
Dexpramipexole
n=20 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Age, Customized
< 50 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
50 to 65 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
CSNP-E Symptoms
Anterior and/or posterior mucopurulent drainage
|
20 Participants
n=5 Participants
|
|
CSNP-E Symptoms
Sinonasal obstruction/congestion
|
20 Participants
n=5 Participants
|
|
CSNP-E Symptoms
Decreased sense of smell (anosmia)
|
20 Participants
n=5 Participants
|
|
Duration of Symptoms (months)
|
112.4 months
STANDARD_DEVIATION 138.13 • n=5 Participants
|
|
Duration of symptoms
≤ 1 year
|
3 Participants
n=5 Participants
|
|
Duration of symptoms
> 1 year to ≤ 5 years
|
6 Participants
n=5 Participants
|
|
Duration of symptoms
> 5 years to ≤ 10 years
|
6 Participants
n=5 Participants
|
|
Duration of symptoms
> 10 years
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: All subjects who had a Month 3 evaluation (on study drug Day 77 or later) for TPS and peripheral blood eosinophil count. Last observation carried forward (LOCF) was used to replace missing data due to drop out. Only Month 3 data or later (assessment date Day 77 or later and within 7 days of last dose) were used.
Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 6 is presented as ratio to baseline.
Outcome measures
| Measure |
Dexpramipexole
n=16 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment
|
0.06 ratio to baseline
Interval 0.023 to 0.154
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: All subjects who had a Month 3 evaluation (on study drug Day 77 or later) for TPS and peripheral blood eosinophil count. Last observation carried forward (LOCF) was used to replace missing data due to drop out. Only Month 3 data or later (assessment date Day 77 or later and within 7 days of last dose) were used.
The change in Nasal Polyp Score (NPS) score after 6 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden.
Outcome measures
| Measure |
Dexpramipexole
n=15 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment
|
0.07 units on a scale
Standard Deviation 1.751
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The safety population included all subjects who received at least 1 dose of study treatment.
Summary of subjects from the safety population who experienced potentially clinically significant values in hand serum chemistry results
Outcome measures
| Measure |
Dexpramipexole
n=20 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Albumin <= 25 g/L
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Alanine aminotransferase (ALT) >= 1.5 x ULN
|
1 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Aspartate aminotransferase (AST) >= 1.5 x ULN
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Total bilirubin >= 1.5 x ULN
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Glucose>= 9.7 mmol/L
|
1 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Glucose <= 2.2 mmol/L
|
1 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Eosinophils > 1.6 x 10(9)/L
|
1 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Hematocrit - Females >=54%
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Hematocrit - Females <= 32%
|
2 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Hemoglobin - Females >=175g/L
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Hemoglobin - Females <= 95g/L
|
2 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
HIGH: Lymphocytes > 12 x 10(9)/L
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Lymphocytes < 0.8 x 10(9)/L
|
2 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
LOW: Neutrophils < 1.5 x 10(9)/L
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The safety population included all subjects who received at least 1 dose of study treatment.
Summary of subjects from the safety population who experienced potentially clinically significant values or changes in vital signs or weight
Outcome measures
| Measure |
Dexpramipexole
n=20 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Systolic Blood Pressure: >180 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Systolic Blood Pressure: increase from pre-dosing of more than 40 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Systolic Blood Pressure: <90 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Systolic Blood Pressure: decrease from pre-dosing of more than 30 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Diastolic Blood Pressure: >105 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Diastolic Blood Pressure: increase from pre-dosing of more than 30 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Diastolic Blood Pressure: <50 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Diastolic Blood Pressure: decrease from pre-dosing of more than 20 mmHg
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Heart Rate: >120 beats per minute
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Heart Rate: increase from pre-dosing of more than 20 beats per minute
|
1 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Heart Rate: <50 beats per minute
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Heart Rate: decrease from pre-dosing of more than 20 beats per minute
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Temperature: >38ºC and an increase from pre-dosing of at least 1ºC
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Body Weight: >7% increase from baseline value
|
0 Participants
|
|
Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
Body Weight: <=7% decrease from baseline value
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The safety population included all subjects who received at least 1 dose of study treatment.
Summary of subjects from the safety population who experienced potentially significant values in electrocardiogram parameters
Outcome measures
| Measure |
Dexpramipexole
n=20 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: >450 msec
|
2 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: >480 msec
|
0 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: > 450 msec and ≤ 450 msec at baseline
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: > 480 msec and ≤ 480 msec at baseline
|
0 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: > 450 msec and change from baseline > 30 msec
|
0 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF: > 480 msec and change from baseline > 30 msec
|
0 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF change from baseline: >30 msec
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
QTcF change from baseline: >60 msec
|
0 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Rhythm abnormalities: Sinus rhythm
|
17 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Rhythm abnormalities: Sinus bradycardia
|
3 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Rhythm abnormalities: Premature atrial complexes, conducted or non-conducted sinus rhythm
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Nonspecific T wave abnormality
|
3 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Early repolarization
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Early repolarization, considered normal variant
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Nonspecific ST deviation
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Nonspecific ST deviation, prolonged QTcF interval
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Nonspecific T wave abnormality, prolonged QTcF interval
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
ST-T abnormalities: Prolonged QTcF interval
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Conduction abnormality: First degree AV block
|
2 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Conduction abnormality: Complete right bundle branch block
|
1 Participants
|
|
Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
Conduction abnormality: Complete right bundle branch block first degree AV block
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: All subjects who had a Month 3 evaluation (on study drug Day 77 or later) for total eosinophil count
Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 3 is presented as ratio to baseline.
Outcome measures
| Measure |
Dexpramipexole
n=16 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment
|
0.05 ratio
Interval 0.019 to 0.142
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: All subjects who had a Month 3 evaluation (on study drug Day 77 or later) for total eosinophil count and total polyp score
The change in Nasal Polyp Score (NPS) score after 3 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden.
Outcome measures
| Measure |
Dexpramipexole
n=16 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Change From Baseline in TPS After 3 Months of Treatment
|
0.0 units on a scale
Standard Deviation 1.414
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 6Population: All subjects who had a Month 3 evaluation (on study drug Day 77 or later) for TPS and peripheral blood eosinophil count (Efficacy Population). Additionally, subjects with \<5 eos/hpf at screening or baseline visit are not included in this analysis.
Change in polyp tissue eosinophil count measured as eosinophils/hpf (high powered field) from baseline to month 6 is presented as ratio to baseline.
Outcome measures
| Measure |
Dexpramipexole
n=12 Participants
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Ratio to Baseline in Polyp Tissue Eosinophil Count After 6 Months of Treatment
|
0.03 ratio to baseline
Interval 0.02 to 0.06
|
Adverse Events
Dexpramipexole
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexpramipexole
n=20 participants at risk
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Metabolism and nutrition disorders
biliary dyskinesia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
Other adverse events
| Measure |
Dexpramipexole
n=20 participants at risk
dexpramipexole 150 mg BID
dexpramipexole: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
2/20 • Number of events 2 • 6 months on treatment
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
General disorders
Oedema
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
General disorders
Xerosis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Folliculitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Number of events 4 • 6 months on treatment
|
|
Infections and infestations
Onychomycosis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Sinusitis
|
40.0%
8/20 • Number of events 12 • 6 months on treatment
|
|
Infections and infestations
Subcutaneous abscess
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
2/20 • Number of events 2 • 6 months on treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Metabolism and nutrition disorders
Polydipsia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 2 • 6 months on treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Nervous system disorders
Sinus headache
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Psychiatric disorders
Middle insomnia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Psychiatric disorders
Sleep disorder
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Intranasal paraesthesia
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.0%
3/20 • Number of events 4 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • 6 months on treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER