Trial Outcomes & Findings for Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema (NCT NCT03728504)
NCT ID: NCT03728504
Last Updated: 2023-05-09
Results Overview
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
ASN002 40 mg
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Baseline characteristics by cohort
| Measure |
ASN002 40 mg
n=33 Participants
40 mg ASN002
ASN002: Daily dose of ASN002
|
ASN002 80 mg
n=32 Participants
80 mg ASN002
ASN002: Daily dose of ASN002
|
Placebo Oral Tablet
n=32 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 16.86 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 15.76 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 16.64 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 16.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
modified Total Lesion Symptom Score (mTLSS)
|
13.2 units on a scale
STANDARD_DEVIATION 3.42 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 2.57 • n=7 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 3.41 • n=5 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 3.13 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPercent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
Outcome measures
| Measure |
ASN002 40 mg
n=33 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
n=32 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
n=32 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
|
-49.5 percentage change
Standard Deviation 40.65
|
-71.3 percentage change
Standard Deviation 26.97
|
-29.9 percentage change
Standard Deviation 38.51
|
SECONDARY outcome
Timeframe: 16 weeksProportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)
Outcome measures
| Measure |
ASN002 40 mg
n=33 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
n=32 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
n=32 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Hand Physician Global Assessment (PGA)
|
7 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 16 weeksReduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear
Outcome measures
| Measure |
ASN002 40 mg
n=33 Participants
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
n=32 Participants
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
n=32 Participants
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Hand Patient Global Assessment (PaGA)
|
7 Participants
|
7 Participants
|
2 Participants
|
Adverse Events
ASN002 40 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
ASN002 80 mg
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Oral Tablet
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASN002 40 mg
n=33 participants at risk
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
n=32 participants at risk
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
n=32 participants at risk
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
Other adverse events
| Measure |
ASN002 40 mg
n=33 participants at risk
40 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
ASN002 80 mg
n=32 participants at risk
80 mg ASN002
ASN002: Daily dose of ASN002 for 32 weeks
|
Placebo Oral Tablet
n=32 participants at risk
Matching placebo for ASN002 doses
Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
15.2%
5/33 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
9.4%
3/32 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • 16 weeks
|
9.4%
3/32 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • 16 weeks
|
18.8%
6/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • 16 weeks
|
18.8%
6/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
1/33 • 16 weeks
|
9.4%
3/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • 16 weeks
|
9.4%
3/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/33 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Abscess limb
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Infections and infestations
Conjunctivitis
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Ear Infection
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Fungal infection
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Oral herpes
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Rash pustular
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Infections and infestations
Tonsillitis
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Infections and infestations
Influenza
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Nervous system disorders
Ageusia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Nervous system disorders
Burning sensation
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Nervous system disorders
Neuralgia
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Nervous system disorders
Sciatica
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
General disorders
Pain
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/33 • 16 weeks
|
6.2%
2/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
General disorders
Face oedema
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
General disorders
Fatigue
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
General disorders
Thirst
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Investigations
Blood CPK increased
|
3.0%
1/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Blood potassium increased
|
6.1%
2/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Blood urine present
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Neutrophil count increased
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
Weight increased
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Investigations
C-reactive protein increased
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Immune system disorders
Seasonal allergy
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/33 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/33 • 16 weeks
|
3.1%
1/32 • 16 weeks
|
0.00%
0/32 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place