Trial Outcomes & Findings for Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI (NCT NCT02859727)
NCT ID: NCT02859727
Last Updated: 2026-03-30
Results Overview
Number of participants with adverse events reported, including serious adverse events
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
37 participants
Primary outcome timeframe
6 years 3 months
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
CDZ173
140mg/day
CDZ173: 140 mg/day
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
CDZ173
140mg/day
CDZ173: 140 mg/day
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Study termination
|
25
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI
Baseline characteristics by cohort
| Measure |
CDZ173
n=37 Participants
140mg/day
CDZ173: 140 mg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
22.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 years 3 monthsPopulation: Number of participants with adverse events reported, including serious adverse events
Number of participants with adverse events reported, including serious adverse events
Outcome measures
| Measure |
CDZ173
n=37 Participants
140mg/day
CDZ173: 140 mg/day
|
CDZ173 After 1 Year
140mg/day after one year
|
CDZ173 After 3 Years
140mg/day after three years
|
CDZ173 After 4 Years
140mg/day after four years
|
CDZ173 After 5 Years
140mg/day after five years
|
|---|---|---|---|---|---|
|
To Evaluate the Number of Participants With (S)AEs During Treatment With CDZ173
|
37 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, after 1 year, after 3 years, after 4 years and after 5 years of study participationPopulation: SF-36 general health score during participation in study
SF-36 (Short Form 36) Survey general health score per participant reported for duration of particpation in study. Scores are reported on a scale of 0 - 100. All items are scored so that a high score defines a more favorable health state.
Outcome measures
| Measure |
CDZ173
n=37 Participants
140mg/day
CDZ173: 140 mg/day
|
CDZ173 After 1 Year
n=37 Participants
140mg/day after one year
|
CDZ173 After 3 Years
n=27 Participants
140mg/day after three years
|
CDZ173 After 4 Years
n=22 Participants
140mg/day after four years
|
CDZ173 After 5 Years
n=10 Participants
140mg/day after five years
|
|---|---|---|---|---|---|
|
To Evaluate the Long Term Efficacy of CDZ173 Using SF-36 General Health Score
|
36.540 score on a scale
Interval 18.95 to 60.32
|
46.050 score on a scale
Interval 26.08 to 66.5
|
48.430 score on a scale
Interval 29.41 to 62.7
|
48.430 score on a scale
Interval 34.17 to 62.7
|
47.240 score on a scale
Interval 36.54 to 57.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 252 daysResponder analysis soluble protein biomarkers - Change in naïve b cells from baseline up to Day 252
Outcome measures
| Measure |
CDZ173
n=5 Participants
140mg/day
CDZ173: 140 mg/day
|
CDZ173 After 1 Year
n=5 Participants
140mg/day after one year
|
CDZ173 After 3 Years
n=5 Participants
140mg/day after three years
|
CDZ173 After 4 Years
140mg/day after four years
|
CDZ173 After 5 Years
140mg/day after five years
|
|---|---|---|---|---|---|
|
Responder Analysis Soluble Protein Biomarkers - naïve B Cells
|
58.16 percentage of naive B cells
Standard Deviation 20.922
|
23.58 percentage of naive B cells
Standard Deviation 16.177
|
32.42 percentage of naive B cells
Standard Deviation 25.293
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and D252Population: PD analysis set
Participants were scanned through MRI or CT imaging
Outcome measures
| Measure |
CDZ173
n=12 Participants
140mg/day
CDZ173: 140 mg/day
|
CDZ173 After 1 Year
n=12 Participants
140mg/day after one year
|
CDZ173 After 3 Years
140mg/day after three years
|
CDZ173 After 4 Years
140mg/day after four years
|
CDZ173 After 5 Years
140mg/day after five years
|
|---|---|---|---|---|---|
|
Sum of Product of Diameters (SPD) of Index Lesions
|
1648.283 mm2
Standard Deviation 1754.6045
|
565.125 mm2
Standard Deviation 424.4619
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and D252Population: PD analysis set
Participants were scanned through MRI or CT
Outcome measures
| Measure |
CDZ173
n=12 Participants
140mg/day
CDZ173: 140 mg/day
|
CDZ173 After 1 Year
n=12 Participants
140mg/day after one year
|
CDZ173 After 3 Years
140mg/day after three years
|
CDZ173 After 4 Years
140mg/day after four years
|
CDZ173 After 5 Years
140mg/day after five years
|
|---|---|---|---|---|---|
|
Spleen Organ Evaluation - Volume in mm3
|
606893.175 Organ volume in mm3
Standard Deviation 349359.8341
|
385025.500 Organ volume in mm3
Standard Deviation 228724.7324
|
—
|
—
|
—
|
Adverse Events
CDZ173
Serious events: 10 serious events
Other events: 34 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CDZ173
n=37 participants at risk
140mg/day
CDZ173: 140 mg/day
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Vascular disorders
deep vein thrombosis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Vascular disorders
Hypotention
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Vascular disorders
Orthostatic hypotension
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
General disorders
Facial pain
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Immune system disorders
Anaphylactic reaction
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Psychiatric disorders
Suicidal ideation
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Investigations
Alanine aminotrasferase increased
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Cardiac disorders
Angina pectoris
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Cardiac disorders
Cardiac arrest
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Nervous system disorders
Paraesthesia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Anal fissure
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Colitits
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Pneumonia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Abscess
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Acute sinusitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
COVID-19
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Parotitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Periorbital cellulitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Viral infection
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Metabolism and nutrition disorders
Hypcalcaemia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
1/37 • Number of events 1 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
Other adverse events
| Measure |
CDZ173
n=37 participants at risk
140mg/day
CDZ173: 140 mg/day
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
COVID-19
|
32.4%
12/37 • Number of events 12 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
27.0%
10/37 • Number of events 10 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Sinusitis
|
16.2%
6/37 • Number of events 6 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Otitis externa
|
18.9%
7/37 • Number of events 7 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
6/37 • Number of events 6 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Rhinitis
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
gastroenteritis
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Pneumonia
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Respiratory tract infection
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Bronchitis
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Oral herpes
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Pharyngitis
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Urinary traxt infection
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Herpes zoster
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Otitis media
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Conjunctivitis
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Conjunctivitis allergic
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Folliculitis
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Herpes simplex
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Influenza
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Lyme disease
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Otitis media acute
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Infections and infestations
Paronychia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Metabolism and nutrition disorders
Obesity
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
General disorders
Influenza like illness
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
General disorders
Non Cardiac chest pain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Immune system disorders
seasonal allergy
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Psychiatric disorders
Illusion
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Investigations
weight increased
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Investigations
Aspartate amoniotransferase increased
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Investigations
SARS-CoV-2 test negative
|
40.5%
15/37 • Number of events 15 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Injury, poisoning and procedural complications
Joint injury
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Nervous system disorders
Headache
|
21.6%
8/37 • Number of events 8 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Nervous system disorders
Migraine
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Nervous system disorders
Paraesthesia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Dental caries
|
10.8%
4/37 • Number of events 4 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Haematochezia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Gastrointestinal disorders
Anal fissure
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
3/37 • Number of events 3 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
5.4%
2/37 • Number of events 2 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
5/37 • Number of events 5 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
|
General disorders
pyrexia
|
24.3%
9/37 • Number of events 9 • Adverse events are collected throughout participation in the study, from signing informed consent up to the last study visit (EoS). Study duration differs per participant with a maximum of 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place